Public Workshop – Appropriate Use of Consensus Standards

December 7, 2022

Okay.

Scott Colburn: Hello and welcome to the Appropriate Use of Consensus Standards Public Workshop. My name is Scott Colburn, and I'm the director of the Standards and Conformity Assessment Program, or SCAP, at FDA. I'm joined here today with Dr. Terry Woods, whom I'm sure many of you already know, and who serves as SCAP's chief engineer. I'd like to thank all of you for joining us today as we discuss how FDA can make use of the consensus standards in device submissions easier and more efficient. Before we begin, there are a couple of housekeeping items we need to address. First, please keep your microphone on mute unless you are speaking, which we will permit and encourage later in the program. Second, we ask that if you wish to speak, please use the Raise Your Hand function. That way we can call on you and your microphone can be unmuted.

Hello, and welcome to the appropriate <unk> consensus standards public workshop.

And any stockholder and I'm the director of the standards in Colombia Assessment program R. S cap at FDA.

I'm joined here today with Dr. Terry Woods from I'm sure. Many of you already know and who serves as our Scotts chief engineer.

Okay.

I'd like to thank all of you for joining us today as we discuss our FDA can make use of the consensus standards and device submissions easier and more efficient.

Before we begin there are a couple of housekeeping items, we need to address first please keep your microphone on mute unless youre speaking, which we will commit and encourage later in the program.

We ask that if you wish to speak please use the raise your hand function that way, we can call on you and your microphone can be unloaded.

Scott Colburn: Finally, if you prefer not to speak but still have a question or something to contribute, you may use the Q&A button. Note that the chat button is disabled for this workshop. If you want to comment or submit a question in writing, you must use the Q&A button. I'll remind you of those options. Oh, excuse me. I'll remind you of those options again later in the workshop. Whichever method of communication you choose, please know that we welcome your input. This event is called a workshop because we hope and expect to hear your thoughts and responses to today's working questions. We have 2 hours today to address the workshop overarching goal of soliciting input on how FDA can enhance the use of standards and device submissions, and how ultimately we can improve the appropriate use of voluntary consensus standards and premarket submissions for medical device guidance.

Finally, if you prefer not to speak but still have a question or something to contribute may use the Q&A button.

Note that the chat button is disabled for this workshop, if you want to comment or submit a question in writing you must use the Q&A button.

I'll remind you of those options.

Okay.

I'll remind you of those options again later in the workshop.

Whichever whichever method of communication, we choose please know that we welcome your input this.

This event is called a workshop, because we hope and expect to hear your thoughts and responses to today's working questions.

We have two hours today to address the workshop overarching goals solicited input on how FDA can enhance the use of standards and device submissions and how ultimately we can improve the appropriate use of voluntary consensus standards and premarket submission for medical device guidance along handle for an important foundational guidance that we essentially referred to as.

Scott Colburn: A long title for an important foundational guidance that we affectionately refer to as the appropriate use guidance. The agenda will proceed as follows. Terry will first share the background presentation with us, after which we'll turn to three working questions designed to obtain feedback from you. These questions are, how can the FDA advance the use of declarations of conformity to FDA-recognized standards? Two, how can the FDA make it easier for medical device submitters to include the correct supplemental documentation for the standards they cite? And three, what tools and resources do medical device submitters need to encourage the appropriate use of FDA-recognized standards in their medical device submissions? I plan to conclude the workshop after we address the working questions.

The appropriate risk guidance.

The agenda will proceed as follows.

Terry will first take share will first share the background presentation with us after which we'll turn to three working questions designed to obtain feedback from you.

These questions are.

How can the FDA advanced the use of declarations of conformity to FDA recognized standards.

Two.

How can the FDA make it easier for medical device meters to include the correct supplemental documentation for the standards based site.

And three what tools and resources to medical devices meters need to encourage the appropriate use of FDA recognized standards and their medical device submissions.

I plan to conclude the workshop after we address the working questions.

Scott Colburn: Now I'll turn it over to Terry, who will walk us through some background information to prepare us to discuss our working questions later in the workshop. Terry.

Now I'll turn it over to Terry who will walk us through some background information to prepare us to discuss our working questions later in the workshop Gerry Thanks, Scott and good afternoon, everyone.

Terry Woods: Thanks, Scott, and good afternoon, everyone. I'd like to begin by sharing SCAP's vision and mission. Our vision is as follows. The Standards and Conformity Assessment Program leads the medical device community in the enhancement and use of consensus standards in the design, development, and evaluation of health technologies across their lifespans. SCAP solves problems and anticipates opportunities to protect and promote public health through the use of high-quality, regulatory-ready consensus standards. As I will share with you in the following slides, all our work in SCAP is centered on advancing both the quality and the use of consensus standards. Next slide. SCAP's mission describes how we support our vision. SCAP drives the development, recognition, and appropriate use of regulatory-ready standards for medical devices throughout their lifecycles. We produce and implement clear policies and programs to optimize the appropriate use of standards in regulatory processes.

Like to begin by sharing yes, cat's vision and mission.

Our vision is as follows.

Our CNR settled conformity assessment program leads to medical device community enhancement and use a consent as standards in the design development and evaluation of health technologies across their lines.

As tap solves problems and anticipates opportunities to protect and promote public health through the use of high quality regulatory ready consensus statements.

As I will share with you on the following slides all our working cap is centered on advancing both the quality and the use of consensus standards next slide.

<unk> mission describes how we support our vision.

It kept drives the development recognition and appropriate use of regulatory ready standards for medical devices throughout their lifecycle.

We produce and implement clear policies and programs to optimize the appropriate use of standards and regulatory processes.

Terry Woods: We anticipate the need for and lead the development of national and international consensus standards and advance initiatives to enhance confidence in conformity assessment activities. Our work fosters innovation and standardization in technologies that provide platforms for regulatory science to meet novel challenges, and we provide leadership in outreach and global harmonization. Finally, SCAP serves as a resource for FDA staff, industry, other regulatory authorities, and standards development organizations. What this mission means is that SCAP takes a Total Product Life Cycle approach to standards. We work to promote standards, their quality, and their use. In our next slide, you'll see that we've organized ourselves to do just that. Next slide, please. SCAP has three key main functions depicted here across the total standards lifecycle, standards development, standards recognition, and conformity assessment.

We anticipate the need for and lead the development of National and international consensus standards and advance initiatives to enhance confidence in performing assessment activities.

Our work fosters innovation and standardization and technology that provides platforms for regulatory science to meet novel challenges and we provide leadership.

And outreach and global harmonization.

Finally, as kept serves as a resource correct, you'll staff industry other regulatory authorities and standards development organizations.

What this mission. It means is that as cap takes a total product lifecycle approach the standards we.

We work to promote standards their quality and their use.

And our next slide you'll see that we've organized ourselves to do just that.

Next slide please.

And cap has remained.

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Standards development and its recognition.

Formative assessment.

Terry Woods: We have 16 SCAP staff and are able to tap into the expertise of hundreds of volunteer standards liaisons across FDA to drive these three functions. SCAP itself is run like a standards development organization with transparency, precision, and with an eye always toward anticipating future medical device needs. Our overarching goal is to encourage the development and use of high-quality standards that are fit for regulatory use. Let's first look at standards development. FDA believes that contributions from regulatory authorities to standards development are critically important to promote individual and public health. Building regulatory needs into standards means they will be more useful for manufacturers as well as for us.

We have 16 has kept staff and are able to tap into the expertise of hundreds of volunteer standards liaisons across F D. A to drive the certain functions.

At cap itself is run like a standards development organization.

Okay.

Good morning.

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At cap itself is run like a standard development organization with transparency and precision and with an eye always taught anticipating future medical device needs.

Our overarching goal is to encourage the development and use of high quality standards that are fit for regulatory news.

Let's first look at standards development.

Ta believes that contributions from regulatory authorities to standards development are critically important in both individual and public health.

Building regulatory needs into standards and they will be more useful for manufacturers as well as for us.

Terry Woods: SCAP manages about 400 center staff who, in addition to their day jobs, whether that's device evaluation, post-market analysis, or regulatory research, participate in more than 600 standards development organization technical committees, subcommittees, and working groups. Sometimes we're the only regulator at the table. A key component in this standards development work is our Specialty Task Groups or STGs. STGs align with our regulated device areas from horizontal aspects like quality systems and risk management to the vertical or specific device areas such as cardiology, orthopedics, and radiology. STG members are experts in regulatory policy, engineering, medicine, and science from different offices across FDA. The STGs serve as internal advisory committees to SCAP. Our STGs use the consensus process throughout the lifecycle of standards, from identifying the need for a new standard all the way through standards development or revision, and finally, formal recognition.

If cap manages about 400 center staff.

In addition to their day jobs, whether that's device evaluation post market analysis or regulatory research.

Participate in more than 600 standards development organization technical committees Subcommittee and working groups some.

Sometimes we're the only regulator at the table.

A key component in the standards developed more is our special attachments or S. T. G I F.

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Seg members are experts and regulatory policy engineering Medicine and science.

From different offices across SBA.

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Our FPGA is he's the consensus process throughout the lifecycle of standards from identifying the need for a new standard all the way through standards development of revision and finally formal recognition.

Terry Woods: Now let's talk about our standards recognition program. The term recognition refers to the mechanism by which FDA identifies a published standard to which device manufacturers may declare conformance in order to meet a relevant requirement. It is a formal, rigorous, and transparent process that I'll discuss in greater detail in the next few slides. The important thing to take away from this introduction to our recognition program is that if a manufacturer declares conformity to a recognized standard, the amount of supplemental documentation needed for the device submission goes way down. More on that in a moment also. Currently, we recognize more than 1,400 standards, a number that increases by 5% to 10% every year. An internal standards utilization study demonstrated that an average of 7 standards are cited in each 510(k) submission. Finally, onto conformity assessment. Once standards are recognized, now what?

Now, let's talk about our standards recognition recognition program.

The term recognition refers to the mechanism by which FDA identifies the published standards to which device manufacturers may declare performance in order to meet irrelevant requirement.

As a formal rigorous and transparent process that I'll discuss in greater detail in the next few slides.

The important thing to take away from this introduction to a recognition program is that if a manufacturer declares conformity to a recognized standard the amount of supplemental documentation needed for the device submission goes way down.

More on that in a moment offset.

Currently we recognize more than 1400 standards, a number that increases by 5% to 10% of the year.

An internal standards utilization study demonstrated that an average of seven standards decided in which five 10-K submission.

And.

Finally entrepreneur formative assessment.

<unk> standards are recognize now what.

Terry Woods: We need to put recognized standards to work, which leads to another important element of our total standards life cycle, conformity assessment. A key priority of our conformity assessment work is to promote the use of declarations of conformity in device submissions. We have implemented a new program, the Accreditation Scheme for Conformity Assessment, or ASCA, to do just that. We won't have time to discuss ASCA in great depth today, but its goals are to enhance confidence in medical device testing, promote consistency and predictability in pre-market review, encourage effective use of FDA resources, and support international harmonization. We encourage you to visit the ASCA web pages to learn more about how ASCA can streamline the conformity assessment aspects of device review. We'll share the links later in this presentation. Next slide, please. I promised you more information on our recognition program, so here goes.

We need to put recognized standards to work, which leads to another important element of our total standard slide cycle conformity assessment.

Okay.

A key priority of our conformity assessment work is to promote the use of declarations conformity and device submissions.

And we've implemented a new program the explanation scheme for conformity assessment or ask us to do just that.

We won't have time to discuss asset in great depth today that its goals are to enhance confidence in medical device testing promote consistency and predictability in pre market review.

Encourage effective use of FDA resources and support internal international harmonization.

We encourage you to visit the ask of web pages to learn more about how Africa can streamline the conformity assessment aspect of the bice reviewed.

Sure. The links later in this presentation.

Next slide please.

I promised you more information on our recognition program. So here goes.

Terry Woods: You can find this information and more on the SCAP webpage and in the guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards. As I mentioned on the previous slide, recognition is FDA's formal identification of a standard to which it is appropriate for device manufacturers to declare conformance in order to satisfy part of a premarket review requirement. Now, our standards recognition program is a central part of what we do. To repeat, we run the recognition program like an SDO-run standards development in an open, inclusive, and transparent manner. Why do we recognize certain consensus standards in the first place? Well, it signals to product developers that FDA considers the standard to be appropriate for use.

You can find this information and more on the F cap webpage.

And in the guidance and titled recognition and withdrawal of voluntary consensus statements.

As I mentioned on the previous slide recognition is fda's formal identification of a standard to which it is appropriate for device manufacturers to declare conformance in order to satisfy part of our pre market review requirement.

Now our standards recognition program is a central part of what we do and to repeat we run the recognition program like an <unk> standards development and an open inclusive and transparent manner.

Finally recognized certain consensus standards in the first place.

Well it signals to product developers that FDA considers the standard to be appropriate for us.

Terry Woods: If a manufacturer elects to conform to one or more recognized standards to meet a premarket review requirement, they can submit a Declaration of Conformity in their submission, which generally reduces the amount of documentation that will be required. This should help streamline the conformity assessment elements of the device review. We'll talk more about declarations of conformity in a bit, but I wanted to introduce them and their advantages here. Before I go into how FDA staff approach recognition decision-making, note that we can recognize all or only part of a standard. Since we are committed to transparency, we publish our reasoning or rationale for each decision. These decisions can be found in our Recognized Consensus Standards database, which is available to everyone. There's also a database for standards we specifically choose not to recognize.

If a manufacturer elects to conform to one or more recognized standards to meet a premarket review requirement. They can submit a declaration of conformity and their submission, which generally reduces the amount of documentation that will be required.

This should help streamline the conformity assessment elements of the device reviews.

We'll talk more about declarations of conformity and a bit but I wanted to introduce them in their advantages here.

Before I go into how FDA staff approach recognition decision, making note that we can recognize all <unk>.

As part of a standard.

And since we are committed to transparency, we publish our reasoning or rationale for each decision.

These decisions can be found in our recognized consensus standards database, which is available to everyone.

There's also a database for standards, we specifically chose not to recognize.

Terry Woods: Finally, we keep an eye on standards and revisions through the standards development work I talked about earlier. That way we know when to update our recognition database or even withdraw standards that are no longer suitable for recognition. Next slide, please. Here's how the recognition decision-making process proceeds. First, someone submits a request for recognition. This can be anyone inside or outside the FDA. We acknowledge the request with a formal communication and convene the appropriate Specialty Task Group, which is the group of experts I mentioned before, to formally review the standard and make a recommendation to SCAP. SCAP then decides whether to recognize the standard or not. If we do recognize it, we'll state the extent of our recognition. In other words, will we recognize the complete standard or only part of it?

And finally, we keep an eye on standards and revisions through the standards development work I talked about earlier that.

That way, we know when to update our recognition database or even withdraw standards that are no longer suitable for recognition.

Next slide please.

Okay.

Here's how the recognition and decision making process proceeds.

First someone submits a request for recognition.

As can be anyone inside or outside the FDA.

We acknowledge the request with a formal communication and convening appropriate specialty task.

Which is the group of experts I mentioned before.

To formally review the standard and make a recommendation to essakane.

<unk> been to slides whether to recognize the standard or not if.

If we do recognize it both state the extent of our recognition.

Other words, where we recognized standard are only part of it.

Terry Woods: Finally, we will add the standard to the Recognized Consensus Standards database when the next update is published, which is typically twice a year. We include the scientific, technical, regulatory, or other basis for our decision. Currently, we use the Federal Register list to inform the public about updates. At this moment, we're in the process of the second update cycle for this year, which will be List 59. Next slide, please. This is a screenshot of the landing page of our database. You can see it's searchable using several different criteria, including the standards development organization, the designation number, the recognition number, and the title or keywords. Above the search box, there are links you can use to access the previously published FR lists as well. Next slide. Previous slide, please. Okay, can you go to slide 10, please? There we go.

Finally, we will add the standards for the recognized consensus standards database. When the next update is published which is typically twice a year.

We include the scientific technical and regulatory or other basis for our decision.

Currently we use the federal register was to inform the public about updates.

At this moment, we are in the process of the second update cycle for this year, which will be lift 59.

Next slide please.

This is a screenshot of the landing page of our database you can see it searchable using several different criteria, including standards development organization designation number.

Recognize that number and the title or see words.

About the search box there Lance you can use to access the previously published our list as well.

Next slide.

A previous slide please.

Yeah.

Previous slide.

Okay can you go to slide 10 please.

Terry Woods: You will also find other important information in the Recognized Consensus Standards database. For every standard we recognize, we publish what is called a Supplemental Information Sheet, or SIS, containing the information listed on this slide. The SIS is designed as a tool for stakeholders when they use and cite a recognized standard. I won't read all the elements listed here, but I will draw your attention to the last one, relevant guidance documents, and other publications. It is extremely important that manufacturers consult these related documents to learn more about expectations for conformity with the standard. Next slide. Here we have an example for ISO 4823, a dental standard. It includes the extent of recognition. In this case, it's a complete recognition, the rationale, examples of applicable product codes, and additional information. Next slide, please.

There you.

You will also find out other important information and recognize consensus standards database for every standard we recognize he published what is called a supplementary information sheet or S. I S containing the information listed on this slide.

<unk> is designed as a trough for stakeholders, who may use in spite of recognized standards.

Don't read all the elements listed here, but I will draw your attention to the last one relevant guidance documents and other publications.

Is extremely important that manufacturers consult these related documents to learn more about expectations for conformity with the standard.

Next slide.

Here, we have an example.

For ISO 48, 23, a dental standard and includes the extent of recognition in this case, it's a complete recognition the rationale examples of applicable product codes and additional information.

Next slide please.

Terry Woods: ANSI/AAMI HE75 for human factors is an example of a standard that has a partial recognition. It does not feature acceptance criteria or test methods, and so when citing this standard, manufacturers will need to submit complete test reports. More on what to submit shortly. Notice in particular that on this SIS, we have directed users to consult the key guidance on usability testing. Next slide. All that being said, the use of consensus standards is voluntary. FDA strongly recommends it for all the reasons we just talked about, but their use by a manufacturer is voluntary, unless a standard is incorporated by reference into a regulation, which is a rare thing for medical devices. If a manufacturer wishes to demonstrate conformity to expectations in other ways, that's up to them to decide. They will just need to justify their approach.

Anti Amy <unk> 75 for human factors is an example of a standard that has a partial recognition.

It does not feature acceptance criteria or test methods and so when fighting this standard manufacturers will need to submit complete test reports.

More on what to submit shortly but noticed in particular that I'll Miss S. I S with Directv users to consult a key guidance on usability testing.

Next slide.

All that being said the use of consensus standards is voluntary.

FDA strongly recommend it for all the reasons, we just talked about but they are used by many expert is voluntary unless a standard is incorporated by reference for regulation, which is a rare thing for medical devices.

If a manufacturer wishes to demonstrate conformity to expectations in other ways, that's up to them to decide they will just need to justify their approach.

Terry Woods: Now, standards may be cited in any type of submission, including PMA, 510(k), and others. As we discussed, if a standard is recognized by FDA, a Declaration of Conformity may be used. General use of a standard is also an option with any standard, recognized or not. Just keep in mind that additional documentation will be needed. Next slide. What is a Declaration of Conformity? A Declaration of Conformity is an attestation from the manufacturer that the device conforms to all the requirements of a standard. It confirms to FDA that all normative requirements have been met, that all testing has been conducted, and that those tests were performed on a finished or final finished device. If the submitter is declaring conformity to an FDA-recognized standard, a Declaration of Conformity should be included in the premarket submission.

Now standards may be cited in any type of submission, including PMA file 10-K and others.

And as we discussed at the standard is recognized by FDA, a declaration of conformity may be used.

General use of our standard is also an option with any standard recognized or not.

Just keep in mind that a dicks additional documentation of needed.

Next slide.

So what is a declaration conformity.

A declaration of conformity is an attestation from the manufacturers, but the device conforms to all the requirements of the standard.

It confirms to FDA, but all normative requirements have been met.

They're all testing has been conducted.

And that those tests were performed on a finished or final finished device.

If the submitter is declaring conformity to an FDA recognized standards a declaration of conformity should be included in the free market submission.

Terry Woods: Using a Declaration of Conformity generally reduces the amount of supplemental documentation needed in a submission, which in turn supports the least burdensome approach to regulatory review. Next slide. Before we turn to a discussion of when and what types of supplemental documentation may be needed, recall that use of recognized standards and the submission of a Declaration of Conformity are voluntary. That means manufacturers may also use other non-recognized consensus standards under the general use provision, as well as use a recognized standard without a Declaration of Conformity. Also, in some cases, when deviations are made to the methodology and the standards, a Declaration of Conformity may not be possible, so it will fall under general use. In these cases, since Declarations of Conformity are not submitted, complete test reports should be included as part of the submission.

Using a declaration of conformity generally reduces the amount of supplemental documentation needed in our submission, which in turn supports Elyse burdensome approach to regulatory review.

Next slide.

Before we turn to a discussion of when and what types of supplemental documentation may be needed recall that use a recognized standards and the submission of a declaration of conformity of voluntary.

Ames manufacturers May also use other non recognized consensus standards under the general use protection as well as user recognized standard without a declaration of informally.

Also in some cases when deviations were made to the methodology and the standards are.

A declaration of conformity may not be possible.

So Paul under general use.

In these cases since declarations of conformity or not submitted complete test reports should be included as part of the submission.

Terry Woods: These reports will require review by FDA, which adds time to the review process. Next slide, please. Let's talk more about what we mean by supplemental documentation. Supplemental documentation is information needed to support a Declaration of Conformity. You can see here that it's pretty clear when supplemental documentation will be needed, when neither test methods nor acceptance criteria are called out in the standard, and when a manufacturer has deviated from the standard. In these cases, FDA will want to see the complete test reports. If a manufacturer decides to cite a non-recognized standard under general use, even more documentation will typically be needed. For example, the verification and validation of test methods and acceptance criteria. Next slide.

These reports will require review by FDA, which adds time to the review process.

Next slide please.

I'll talk more about what we mean by supplemental documentation.

Supplemental documentation is information needed support a declaration of conformity.

You can see here that it's pretty clear when supplemental documentation will be needed.

When neither test methods, nor acceptance criteria are called out in the standard.

And when a manufacturer has deviated from the standard.

In these cases FDA will want to see the complete test reports.

And if a manufacturer decides to fight a non recognized standard under general use even more documentation will typically be needed for example, the verification and validation of test methods and acceptance criteria.

Next slide.

Terry Woods: This table, adapted from the current Appropriate Use of Voluntary Consensus Standards guidance document, outlines when and what sorts of supplemental documentation are needed when a standard is cited in a device submission. As you can see in the first scenario in the yellow box, sometimes a standard includes a test method but no acceptance criteria. In those cases, the complete test report is not needed, but supplemental documentation should include the acceptance criteria the manufacturer tested to and a summary of the results. Next slide. Our next scenario is the opposite case. The standard may include acceptance criteria but does not specify a test method. As in the previous case, a complete test report is not needed, but manufacturers should submit supplemental documentation about the test methods or protocols they chose and why they chose them. Next slide.

This table adapted from the current appropriate use of voluntary consensus standards guidance document outlines when and what sorts of supplemental documentation are needed when a standard decided in a device submission.

As you can see in the first scenario in the yellow box, sometimes a standard includes a test method, but no acceptance criteria.

In those cases.

Fleet Test report is not needed, but supplemental documentation should include the acceptance criteria the manufacturer tested shoe and a summary of the results.

Next slide.

Our next scenario is the opposite case. The standard may include acceptance criteria, but does not specify a test method.

And then the previous case, a complete test report is not needed, but manufacturers should submit supplemental documentation about the test methods were protocols they chose and why they chose.

Next slide.

Terry Woods: The third line in the table, outlined in red, is our worst case scenario. Neither test methods nor acceptance criteria are included in the standard. For those standards, manufacturers need to submit the complete test report. Next slide, please. As you can see in our final scenario outlined in green. When both test methods and acceptance criteria are called out in the standard and manufacturers use and apply them as written, FDA doesn't need any supplemental documentation. This is the best case scenario as it can save manufacturers and FDA a significant amount of time. One caveat, sometimes standards offer choices in test methods. When that's the case, manufacturers should let FDA know what they chose and why. Next slide, please. In summary, when are complete test reports needed? It's simple.

A third line in the table outlined in Red is our worst case scenario either test methods such as criteria are included in the standard.

Are those standards manufacturers need to submit a complete test report.

Next slide please.

As you can see in our final scenario outlined in the brain when both test methods and acceptance criteria are called out in the standards and manufacturers use and apply them as written S. EIA FTA doesn't mean any supplemental documentation.

Is the best case scenario as I can say manufacturers in F. D. A a significant amount of time.

One caveat, sometimes standards offer choices and test methods. When that's the case manufacturers should let FDA now, but they chose and why.

Next slide please.

In summary, when our complete test reports needed.

Terry Woods: When a Declaration of Conformity is not submitted, when there are neither test methods nor acceptance criteria in the standard, and when the sponsor has made deviations or adaptations to the recognized standard. With that, I'll turn it over to Scott, who will lead our discussion of our working questions. Thank you very much.

It's simple on a declaration of conformity has not submitted.

When there are neither test methods, nor acceptance criteria in the standard.

And when the sponsor has made deviations or adaptations to the recognized standard.

So with that I'll turn it over to Scott, who will lead our discussion of Albertsons questions. Thank you very much.

Scott Colburn: Thank you, Terry. Thanks for doing the hard part of all this for us. It's time to switch gears and hand the microphone over to you, our valued stakeholders. Before we do so, I see that we have two hands up, and we're gonna take those questions from you before we go into our first question for the panel. I'm gonna ask the group if they can get the question from, I believe it's Cassie Medick. She's muted. Now we can unmute you, I think.

Thank you Terry.

And thanks for doing the hard part of all of this for us.

Time now to switch gears.

Dominic.

Our value.

Okay.

Alright, sorry, there, yes. So now it's time to switch gears and hand, the microphone over to you our valued stakeholders, but before we do so I see that we have two hands up and we're going to take those questions from you before we go into our first question for the panel. So when asked the group of Sei Jin.

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Chelsea metrics.

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Okay.

Cassie Medick: Oh, hi there. I didn't actually submit a question.

[Analyst 1]: Oh, hi there. I didn't actually submit a question.

Oh, Hi, there I didn't actually it's a great question.

Scott Colburn: Oh, we had your hand up. Your hand must be very tired by now.

Had your hand up your hand must be very tired right now oh, sorry about that.

Kavya Shah: Oh, sorry about that.

[Analyst 1]: Oh, sorry about that.

Scott Colburn: Okay. I see the other hand went down right now. That's all right. We just wanted to know the system's working. All right, what we'll do then, we're gonna jump in. We have three questions to ask you today, and we really encourage you to share your thoughts with us in response. As a reminder, you have two ways you can speak up. First, you may raise your hand just like we did, and that we know works in the Zoom screen, and we'll recognize you, at which you can be unmuted. Please know that when you do that, you may be showing up as broadcasted for this video. Secondly, you may wish to click on the Q&A button and type in your question or comment, and we will be monitoring both.

Okay.

And I see the other hand went down right now so thats alright, we just wanted the release you know the systems working sorry, what we'll do then we're going to jump in and we have three questions to ask you today and we really encourage you to share your thoughts with US in response as a reminder, you have two ways you can speed up first you may raise your hand, just like we did in <unk>.

No that works.

And the zoom screening will recognize you have which you can be a muted. Please note that when you do that you may be showing up as broadcasting for this video.

Secondly, you may wish to click on the Q&A button and type in your question or comment and we will be monitoring both again, we wanted to try to keep this as interactive as possible. So before let's go onto the next slide them and read our first question.

Scott Colburn: Again, we wanna try to keep this as, you know, interactive as possible. Let's go on to the next slide then and read our first question. Question one is simple. Given how important declarations of conformity are to the appropriate use of recognized standards, how can we at the FDA encourage manufacturers to use them more often? Or phrased in a different way, what are the obstacles that get in the way of submitting a Declaration of Conformity? All right. I see we have one raised hand. Kavya Shah. Can we bring that person in?

Yes.

Question, one is simple.

Given how important the deca.

Declarations of conformity are to the appropriate use of recognized standards. How can we ask the FDA encourage manufacturers to use them more often.

Or France in a different way what are the obstacles that get in the way of submitting a declaration of conformance.

Right I see we have one raised hand.

So we are sure.

And that person.

Kavya Shah: Hi. I had a question. Can you say that one more time? If a standard has acceptance criteria but not test method, what is required in supplemental documentation?

[Analyst 1]: Hi. I had a question. Can you say that one more time? If a standard has acceptance criteria but not test method, what is required in supplemental documentation?

Hi.

I had a question about what can you say that one more time if there's.

Standard has acceptance criteria, but not test method, what is required and supplemental documentation.

Scott Colburn: All right. Well, we can try to go back there and talk about. You said if there's a test method included but no acceptance criteria?

Okay.

Scott Colburn: All right. Well, we can try to go back there and talk about. You said if there's a test method included but no acceptance criteria?

So alright, well, we can try to go back there and talk about you said if theres a test method included but no acceptance criteria.

Kavya Shah: Actually, the other way. If the standard has an acceptance criteria but no test method, what is required in supplemental documentation?

[Analyst 1]: Actually, the other way. If the standard has an acceptance criteria but no test method, what is required in supplemental documentation?

The other way if the center has an acceptance criteria, but no test method, what is required and supplemental documentation. So typically and again, we're talking possibly about may be under a thousand different standards. So this will be a high level general overview, but if you don't have the test method included but the standard is maybe part of the acceptance criteria to meet what the.

Scott Colburn: Yeah. Typically, and again, we're talking possibly about maybe 1,000 different standards, this would be a high-level general overview. If you don't have the test method included, the standard has maybe called out the acceptance criteria to meet what the area that's being focused on, you know supply in your Declaration of Conformity what you're doing is you're not necessarily needing to justify the acceptance criteria 'cause that's included in the recognized standard. We probably are going to need to see the methods or protocols, possibly, depending on the standard that you use to support how you came to the results, you know, that were in the already in the standard portrayed. Does that make sense?

The area that's been focused on.

Supply in your declaration conformity.

Youre doing is youre not necessarily needed to justify the acceptance criteria. Because that's included in the recognized standards, but we made we probably are going to need to see the methods are protocols, possibly depending on the standard that you used to support how you came to the results in that work.

Jim.

Already in the standard portrayed does that makes sense.

Kavya Shah: Okay. Just a test protocol, but the same acceptance criteria.

[Analyst 1]: Okay. Just a test protocol, but the same acceptance criteria.

So just a tough startup called but the same acceptance criteria.

Scott Colburn: Yeah. You'd wanna make sure you're at least discussing the method, maybe even adding in the protocols. As always, you know, if this is something that would be newer or a brand-new standard, there's nothing wrong with ever trying to contact the review offices to try to get maybe a little bit more specificity too on what is the level of information. Also note that sometimes in our Supplemental Information Sheet, we also cite relevant other tools such as guidance documents or other areas that we may also help outline what the type of information that would be able to support that Declaration of Conformity.

Yes, so you'd want to make sure you're at least discussing the method, maybe even adding in the protocols.

And as always you all if this is something that would be newer or brand new standard theres nothing wrong with ever trying to contact to review offices to try to get maybe a little bit more specificity to on what is the level of information also note that in sometimes in our supplementary information sheet. We also.

Site relevant other tools, such as guidance documents or other areas that we've made may also help outline what's the type of information that would be able to support that declaration of conformity Steve.

Kavya Shah: Okay.

[Analyst 1]: Okay.

Scott Colburn: Just kind of revisiting the topic of Declaration of Conformity and what we really wanna, you know, hear from our stakeholders here. A Declaration of Conformity is, in the most simple terms, a communication tool. We have recognized a standard to which you may submit a Declaration of Conformity. When you communicate to us that you've utilized the standard via a declaration or attestation in that way, you're communicating that you used the standard in accordance to how we've recognized that, whether it's a complete or partial recognition, whether we've cited, please, you know, look at such and such guidance document or even a specific area of a guidance document. When utilizing a standard and calling it out towards a Declaration of Conformity, you're communicating to us that you're using it in the manner which we have tried to describe it through our recognition.

Steve just kind of revisiting the topic of declaration conformity and what we really wanted to hear from our stakeholders here.

Kurdish conformity is no simple terms of communication tool, we have recognized the standard to which you may submit a declaration of conformity when you communicate to us that you utilize the standard.

Exploration or at a station in there.

That way you are communicating that you use the standard in accordance to how we recognize that whether it's a complete or partial recognition, whether we've cited <unk> looked at such and such guidance document or even a specific area of our guidance document when utilizing our standard and calling it out towards a declaration conformity you're communicating.

To us that youre using it in the manner, which we have tried to describe it through our recognition and that helps us a little bit more and not needing to see every piece of data or information. If you were just calling out the standard, citing it or calling it out in what's called general use which Terry talked about earlier in her discussion so I just.

Scott Colburn: That helps us a little bit more in not needing to see every piece of data or information if you were just calling out the standard and citing it, or calling it out in what's called general use, which Terry talked about earlier in her discussion.

Scott Colburn: That, I just want to kind of put that in the most simple terms. Then based upon the construction of the standard, the chart that Terry shared that's also in the Appropriate Use guidance gives a really high-level overview of what may be necessary in that supplemental documentation to support your Declaration of Conformity.

Wanted to kind of put that in the most simple terms and then based upon the construction of the standard the chart that Terry shared that's also in the appropriate use guidance gives a really high level overview overview of what may be necessary in that supplemental documentation to support your declaration of conformance.

Kavya Shah: Okay. Another question was, if a standard has acceptance criteria and test method both, but the test method is not feasible for the device, so you go ahead and take the acceptance criteria but develop your own test method or protocol, would you declare that as general use?

[Analyst 1]: Okay. Another question was, if a standard has acceptance criteria and test method both, but the test method is not feasible for the device, so you go ahead and take the acceptance criteria but develop your own test method or protocol, would you declare that as general use?

Okay.

And.

The question was if a standard has.

Acceptance criterion test method bolt, but the test method is not feasible for the device.

So you go ahead and take the acceptance Gregory up and develop your own test Metro protocol.

Would you declare that as a general use.

Scott Colburn: Yeah. That is more of a deviation, I guess, to a standard that you have, you know, modified the standard in how it was recognized by putting in place your methods and stuff which are not in the standard. That way you'd probably wanna do more of a general use and provide all of that information that would be supporting the document. You could also try, you know. I think that would be the easiest way to communicate to the review team that, you know, you've modified the standard and had to replace, you know, the test methods for whatever reason you would justify. Terry, I'm also gonna just see if you would concur on that one.

Yes, so that is more of a deviation I just to a standard that you are modest.

Modified the standard and how it was recognized by putting in place score.

Assets and stuff, which are not in the standards. So that way you would probably want to do more of a general use and provide all of that information.

That would be supporting the documents.

You could also try it that would be the most I think there'll be the easiest way to communicate to the review team that you modified the standard and had to replace the out of the test methods for whatever reason you would justify Terry.

Terry I'm also going to see if you would.

Terry Woods: Yeah.

Scott Colburn: Just see if that makes sense as well.

Terry Woods: Yeah.

Scott Colburn: Just see if that makes sense as well.

On that one.

Terry Woods: Yeah, I think that makes sense. I guess maybe with that, we can move on to our first question and answer in the Q&A. Zachary asked, creating the pool of consensus standards is part of the process, but a number of them are actively being revised to address changes in safety information. This often leads to the FDA listing being out of date. What efforts are being made to maintain them to the current revision of consensus standards? Well, Zachary, what we do there is, again, we work with the SDOs to have, you know, to publish the most current version.

Does that makes sense, yeah, I think that makes sense and I guess, maybe with that we can move on to our first question and answer in the <unk>.

In the Q&A.

Zachary asks.

Creating a pool of consensus standards as part of the process, but a number of them are actively being revised to address changes in safety information. This also this often leads to the FDA listing being out of date, what efforts are being made to maintain them to the current revision of consensus standards.

Well exactly so what we do there is again we work with.

With the CLS.

You have the <unk> to publish the most current version.

Terry Woods: There is a transition period for each of the recognized standards so that you can reference the previous version and the current version. The other thing is this is all voluntary, and so you can use a more current version of a standard if you know if there's a standard that's published before we've recognized it. Another thing that's happened to keep the recognition lists much more up to date is now, as soon as the standard appears in the recognition list on the website, you can start using that standard.

There is a transition period for each of the recognized standards. So that you can.

So that you can reference.

You can reference the previous version and the current version. The other thing is this is all voluntary and so you can use a more current version of our standard <unk>.

If there if there is a standard that published before we've recognized is another thing that's happened to keep the recognition with.

Much more up to date is now.

As soon as the standard appears in the recognition list on our website.

You can start using that standard and so the federal Register notice will come out somewhat later than that but you can go ahead and start using it as soon as we do.

Terry Woods: The Federal Register notice will come out somewhat later than that, but you can go ahead and start using it as soon as you can start recognizing or you can start using it for declarations of conformity as soon as it shows up in that list. Again, you know, they come out two times a year. Someone else asked how often. There's a spring list and a fall list. Roughly every six months, we update that with the newest versions of standards that are recognized. I guess with that, we could go on to the next comment.

You can start recognizing you can start using it for declarations conformity as soon as it shows up in that list and and again.

They come out two times a year someone else asked how often there is theres a spring lift and a ball list and so roughly every six months, we update that with.

The newest versions of standards that are recognized.

And I guess with that we could go on to the.

To the next comment.

Scott Colburn: Sure. You know, we are looking at your feedback as well, not just questions, but feedback on how we can advance the use of declarations of conformity from our first question to the FDA-recognized standards. There is a comment from Allison. Is there a template provided from FDA for a declaration of conformity? I'm gonna try to hit this answer from two different levels. One, appropriate use guidance talks about what's the information that would be provided in the basic declaration. Those 7 or 8 elements that are outlined in the appropriate use guidance are called out from the use of ISO/IEC 17050-1, which is the main elements discussing what are the standard or standards, the description, you know, all the way down to the supporting documentation of the signature from the responsible person.

Sure.

And we are looking at your feedback as well not just question, but feedback on how we can advance the use of decorations of conformity from our first question to the FDA recognized standards.

There is a comment from Allison is there a template provided from FDA for a declaration conformity and I'm going to try to hit this Stanford from two different levels, one and on appropriate use guidance.

Talks about what's the information that will be provided in the in the base declaration.

Or eight elements that are outlined in the appropriate use guidance are called out from the use of ISO <unk> 17, 50 Dash, one which is the main elements discussing what are the standard or standards.

All the way down to the supporting documentation have those signature from the responsible person. The second part of that declaration conformity is under ISO IC $17 50 Dash, two which is the supporting documentation that would support how you would.

Scott Colburn: The second part of that Declaration of Conformity is under ISO/IEC 17050-2, which is the supporting documentation that would support how you would, you know, advance that discussion on how you've made the attestation of conformance to that standard. Those are the main areas that the appropriate use covers. Now in our pilot program that we have for the Accreditation Scheme for Conformity Assessment, we took an opportunity to provide examples of what a Declaration of Conformity and this summary test report that would accompany a Declaration of Conformity if you so choose to use a testing laboratory that is a part or has been granted ASCA accreditation. With that, we provided examples to the series of standards that are included into that pilot program.

Advanced that discussion on how you made the attestation of conforms to that standard. So those are the main areas of the appropriate use covers now in our pilot program that we have for the accreditation scheme of confirmed the assessment.

Took an opportunity to provide examples of whether declaration conformity and this summary test report that would accompany.

A declaration conformity if you so choose to use a testing laboratory that is a part or has been granted Astro accreditation with that we provided examples to the series of standards that are included into the pilot.

Scott Colburn: That provides the opportunity for us to see more consistent how the areas of the standard were tested and how the discussions that we're looking to see as the minimum amount of information to support a declaration of conformity can help us make those determinations through the course of the review. The thing of the ASCA program is that we have a connection with the conformity assessment bodies to be able to work with them, provide education, learn from them on how they are testing, also working with the accreditation bodies. We've built a relationship, and with that, confidence in our understanding of how they test, which provides a little bit more assurance to how we look at the information that's contained in those reports. Anything else you'd like to add on that one?

Program and that provides the opportunity for us to see more consistent how the areas of the standard were tested and how the discussions that we're looking to see is the minimum amount of information to support a declaration conformity can help us make those determinations through the course of the reviews. The thing of the <unk> program is that we.

Have a connection with the performing assessment bodies to be able to work with them provide education, where I'm from them on how they are testing also working with the accreditation bodies. So we've built a relationship and with that confidence in our understanding of how they test which provides a little bit more assurance to how we look at the <unk>.

Information that's contained in those reports.

Anything else you'd like to add on that one.

Terry Woods: That pretty much covers it.

That pretty much covers it.

Scott Colburn: All right. I think we've hit the next one that says about updating the database two times a year. We, I guess we could say in general, we try to update those, usually late June or early July, and then again, probably coming up here in a few weeks, is when we aim to do that. There are certain circumstances too where some standards come in that is of high priority to the agency, and the leadership is asking we get those into the recognition database earlier. Those do also happen, and we try to announce that through channels like FDA Newsroom and others. We do try to keep that. The Federal Register notices are the thing that accompany later.

So I think we've hit the next one that says about updating the database two times a year.

Right.

Yes, we can say in general we try to update those.

Usually late June early July and then again.

Are we coming up here in a few weeks is when we aim to do that.

There are certain circumstances to where some standards come in that is of high priority to the agency and the leadership is estimated dose into the recognition database earlier in those two also happened and we tried to announce that through channels like FDA news and others.

So we do try to keep that the federal Register notices are those thing that accompany later, but as Terry mentioned, we do have the ability to show.

Scott Colburn: As Terri mentioned, we do have ability to show our intent for recognition through the recognition database and then follow it up through the Federal Register notice when that goes through that process. Take the next one.

So our intent for recognition through the recognition database and then followed up through the Federal Register notice when that goes through that process.

The next one.

Terry Woods: Sure. I guess there's a question about standards that aren't recognized by FDA. The company has used the standards, but does FDA recommend using them in the declaration of conformity in the premarket submission? Now, if a standard isn't recognized, you are perfectly free to use that in your testing, in your device design development, and in your submission. The declaration of conformity only works for recognized standards. Again, if it's not recognized, you're still free to use it, but you would not use that in a declaration of conformity.

Sure I guess is the question about standards that are recognized by FDA.

The company has used the standards, but.

<unk> does FDA recommends.

Using them and the declaration of conformity and premarket submission now if a standard isn't recognized you are perfectly free to use that in your.

In your testing and your device design development in any of your submission, but the declaration of conformity only works for recognized standards. So again, if it is not recognized or so.

Feel free to use it but you would not use that in a declaration of conformity.

Scott Colburn: One of the advantages that the Form FDA 3514 provides, so it's right up front, the review team gets to see which standards are a part of the submission and what is the method that you are utilizing those standards, whether it's towards a declaration of conformity, a declaration of conformity with from the ASCA program, or in its general use. As Terri mentioned, you can also put in standards that may not be recognized. We do try to look at metrics from that from time to time to see, are we seeing a trend of standards that we have not yet recognized that may make sense to do so in the future based upon how members are using, but we have not yet received a formal request for recognition.

The advantages of that $435 14 provide so it's right upfront there.

The review team gets to see which standards are a part of this submission and what is the message that you are utilizing those standards, whether it's towards the declaration conformity of decoration conformity with from the Astra program or and Thats General use and as Terry mentioned you can also put in standards that may not be recognized and we do try to look at metrics from.

From time to time to see are we seeing a trend of standards that we have not yet recognized that may make sense to do so in the future based upon how.

Members are using but we have not yet received a formal request for recognition.

Terry Woods: Right. I guess seeing the comment from Pam Martin saying, "Add the supporting information required for the DOC into the Supplemental Information Sheet." That's precisely the kind of information we're trying to hear from you know. What is it that we can do to make it easier for you to use declarations of conformity? Again, thank you for adding that comment. We will definitely take that into consideration. Again, let us know, you know, what other things can we do to make it easier for you to use a declaration of conformity to recognize standards.

And I guess seeing the comment from Pam Martin, saying at the supporting information required for the GSE into the supplemental information sheet.

That's precisely the kind of information we're trying to hear from you what is it that we can do to make it easier for you to use declarations of conformity. So again. Thank you for for adding that comment we will definitely take that into consideration and again, let us know what other thing.

<unk> can we do to make it easier for you to use a declaration of conformity to recognized standards.

Scott Colburn: Pam, I'll add on to that for your comment there. You know, I think the pie in the sky is that every standard helps outline what a test report should look like. I know we have standards developing organizations on the line. Our call to you would be to work with your technical committees to try to make sure does the standards lend themselves to a declaration of conformity, first and foremost. But secondly, is there a way that you could communicate how that test report would be appropriately constructed? We know certain areas, like in the IEC 60601, there are test report forms developed, and certain other standards also have examples of what needs to be included in a test report.

And Pam I'll add onto that.

Your comment there.

I think the pie in the Sky that every standard helps outline what test report should look like and so I know we have standard developing organizations on the line on our call to you would be to work with your technical committees to try to make sure that this does the standards lend themselves to a declaration of conformity first and foremost secondly is there a <unk>.

That you could communicate how that test report or would.

It would be appropriately constructed certain areas like in the ISC either our test report forms developed in certain other standards also have examples of what needs to be included in a test report, but the more that the standards development can do that the easier I think it is we would want to ensure that how we would look at.

Scott Colburn: The more that the standards development can do that, the easier I think it is because we would want to ensure that how we would look at assessments of conformity in the test reports would be similar to how you would use them in other jurisdictions as well. If it's built into the standard, it's a lot easier for that to take place when we can recognize it in that form versus taking the more arduous task of trying to build that into our own supplementary information sheet. Just a quick note about the Supplemental Information Sheet. The information that we put on there is pretty on a very high level, but it's not intended to be guidance. It's not a guidance document itself, otherwise they would go through a very long process for clearance.

Assessments of conformity of the test reports will be similar to how you would use them in other jurisdictions as well and if it is built into the standard it's a lot easier for that to take place. When we can recognize it in that form versus taking a more arduous task of trying to build that into our own supplementary information sheet and just a quick note about the supplementary.

Information sheet the information that we put on there is pretty either very high level, but it is not intended to be guidance. It's not a guidance document itself otherwise they would go for it through a very long process for clearance.

Scott Colburn: There is minimum amount of information that we can provide that would not already be contained within the standard or something cited within an existing published document. We can go to the next one maybe. I do see one here that I think is pertinent, before maybe we go to even the second question. It says, "Who should sign off on the Declaration of Conformity from a company? Does FDA have any suggestions or comments?" That's a great question. We know over the last couple of years, we have worked with a number of different organizations to try to have this discussion on, you know, who could, you know, who should sign it. Really, from our standpoint, it's who's the responsible person at the company.

So there is a minimum amount of information that we can provide that would not already be contained within the standard or something cited within an existing public stock Smith.

Okay.

The next one.

I do see one here that I think has hurt net before maybe we go to the second question.

It says who should sign off on the declaration comfortably from our company does FCA have any suggestions or comments and Thats a great question. We know over the last couple of years, we have worked with a number of different organizations to try to.

Two.

This discussion on who should sign that really from our standpoint, it's who is the responsible personnel at the at the company I think it even outlines that.

Scott Colburn: I think it even outlines that, within the Declaration of Conformity, information that's in our guidance document. That could be a number of different people depending on how your company is set up. We know too, though, that there is some concerns about signatures, and this is something that we're continuing to try to advance with our office policy as well as within our stakeholder community. If people do have questions or thoughts on this would be something we wouldn't mind hearing from. Maybe we can go to the live one. If we-

Within the declaration conformity.

Information that's in our guidance document.

That debt that can be a number of different people depending on how your company is set up.

We know too though that there is some concerns about signatures and that's just something that we're continuing to try to advance with our ops policy as well as within our stakeholder community. So if people do have questions or thoughts on this would be something we wouldn't mind hearing from.

It will be below that of a lifeline.

Terry Woods: I guess I see one more.

If you would I guess I see one more.

Scott Colburn: Okay.

Terry Woods: One more in the chat. What can SDOs do to help expedite the recognition of standards? Any advice on new technologies such as AI in getting acceptance by FDA? I guess Scott addressed that a little bit, but what we're hoping that the SDOs can do is at the individual committee level, at the level of each individual document that you're working on, think about what information is needed for a Declaration of Conformity or for general use. So if you can, you know, beef up the information in the test reports. Think about the information that needs to be included, either in a Declaration of Conformity or in general use of the standard, and add that. You know, I know the holy grail for test methods is acceptance criteria.

One more in the in the chat.

What can <unk> do to help expedite the recognition of standards any advice on new technologies, such as AI and getting acceptance by FDA.

And I guess, Scott address that a little bit but.

We're hoping that the <unk> can do is at the individual community level at the at the end of <unk> at the level of of each individual document that you're working on think about what information is needed for a declaration of conformity or for general use. So if you can.

Beef up the information in the in the test reports think about the information that needs to be included either in and in a declaration of conformity or in.

Generally these are standard.

And that I know the Holy Grail for test methods as acceptance criteria and I've been in many many discussions trying to come up with the acceptance criteria for specific standards, but anything the individual experts can do to come up with a second criteria will make it that much easier too.

Terry Woods: You know, I've been in many discussions trying to come up with acceptance criteria for specific standards. Anything the individual task groups can do to come up with acceptance criteria will make it that much easier to minimize the amount of information you have to submit to FDA. Again, it's the thinking about making standards regulatory ready, defining the test methods as well as you possibly can. Think of acceptance criteria. Come up with perhaps standard formats for your summary test result, results or for your test reports. Those are things that, you know, every SDO and every specific working group for a document can do to help make standards more regulatory ready.

<unk>.

To minimize the amount of information you have to submit to FDA. So again, it's the thinking about making standards regulatory ready defining the test methods as well as you, possibly can think up acceptance criteria.

Come up with perhaps standard formats or your summary test result results are for your test reports.

These are things that every STL in every specifics working group for a document can do to to help make standards regulatory ready.

Scott Colburn: Okay. Why don't we take a comment from the audience then? If we could, unmute, Jamie, who I think is at the top of the list.

Okay.

Let me take the comment from the audience and if we could on mute Jamie.

I think there is at the top of the list.

[Analyst 1]: Hi, Scott and Terry. Can you hear me?

Hi, Scott and Terry can you hear me, yes, we can very well.

Scott Colburn: Yes, we can. Very well.

[Analyst 1]: Okay, good. Well, thank you so much for hosting this forum. I do have some thoughts both about the question about DOC and also, what you said about updating the database also made me. We had a thought about that as well, which I thought I would take this opportunity to mention, which is, as you note, right, although the primary updates are twice a year, you also do updates throughout the year for very important standards, right? Given what both you and Terry were saying about the fact that the moment it appears in the database that they then can be used for FDA recognition, that it would be helpful, I have heard, to have that information pushed out to industry as soon as possible.

Thank you so much for hosting this forum I do have some Pos both about the question about POC and also what you said about updating the database also made me.

We have we had a thought about that as well, which I thought I would take this opportunity you mentioned, which is as you note right. Although the primary updates our twice a year you also do update throughout the year for the for <unk>.

Very important right and given but both you and Terry were saying about the fact that the moment. It appears in the database that they then can be used for FDA recognition that it would be helpful. We've I've heard to have that information pushed out two industry as soon as possible. So you mentioned.

[Analyst 1]: You mentioned using various forums, existing forums such as, you know, website and that kind of thing. One of the ideas that was suggested to me, and I wanted to pass on to you, was the idea that you could have a subscription, a subscriber type of email list, right? FDA has many of them, and they're sort of general ones for standards, right? You could have a specific one where you would push out notifications any time to this list that people would opt into any time that there was a potential or there was a change, an addition to the standard or a change, right? Changes can be important too, of course, to the database.

And using various forums existing forums, such as website that kind of thing, but one of the ideas that was suggested to me and I wanted to pass on to you was the idea that you could have a subscription.

<unk> type of E Mail list right FDA has many of them and they are sort of general ones for standards right. But then you have a specific one where you would push out notification anytime to this list that people would opt into any time that there was a.

Potential or there was a change in addition to the standard or a change right and important changes can be important to you of course.

Two to the database. So that was just an idea I wanted to share and then did have a response to your first question about the ocs and opportunities for increasing it.

[Analyst 1]: That was just an idea I wanted to share, and then did have a response to your first question about DOCs and opportunities for increasing use.

Scott Colburn: Oh, thank you. Thank you, Jamie. I know we're always looking to find better ways to communicate when an update has been made or significant updates have been made to the recognition database. We do try to communicate that to, you know, through a few channels that go outward. I think the hard thing is I know the agency is large, and it puts out lots of information and things can get missed, when they get shuffled under maybe, you know, 24 hours of communications. That is something we do want to continue to do. I do like your idea of, you know, can we tie a subscription service towards, you know, the database somehow.

Thank you, Jamie and I know, we were always looking to find better ways to communicate when an update has been made or significant updates from may to the recognition database and we do try to communicate that through a few channels that go go outward.

I think the hard thing as I know the agencies large and that puts a lots of information and things to change it missed on when they get shuffled under maybe 24 hours of communications, but that is something we do want to continue to do I do like the idea of can.

Can we tie the subscription service towards yield the database somehow and I think as you know FDA continues to go through enhancing its database. So those are some of the capacity buildings that we can look into so I. Appreciate that you said you had another way of us looking at the debt ratio performance. So yes.

Scott Colburn: I think as, you know, FDA continues to go through enhancing its database and stuff, those are some of the capacity buildings that we could look into. I appreciate that. You said you had another way of looking at the Declaration of Conformity. Why don't you continue?

[Analyst 1]: Yeah. Well, it's more sort of thoughts that have been generated about potential, right, just some potential, maybe challenges to increasing use and, you know, just to get the discussion started and, you know, potential opportunities. 'Cause I know you are very much always looking for ways to improve standards, given your deep commitment and love of standards. Which is essentially-

Well, it's more sort of thoughts that had been generated about potential rate just some potential.

Maybe challenges to increasing use them just to get the discussion started in potential opportunities. Because I know you are very much always looking for ways to improve standards, given your deep commitment and love of standards.

Scott Colburn: We call that being a standards nerd.

Which is all that BMS standard.

[Analyst 1]: Oh my gosh, I'm totally stealing that one. Love it. In any case, what some of the things that have been mentioned is, and you know noted in your explanation, right, is that there are, you know, some quite a few restrictions to when you can actually use the DOC, right? There isn't really a mechanism, or at least I've been told, to say, "You know what? This standard, we really don't believe this standard is applicable to our particular product," or there's some very specific reason, right? That is a potential limitation. The other limitation is there was a question about the signing of the form. That's, and you mentioned there are some concerns surrounding that form, right?

[laughter] Oh, my Gosh I'm following feeling now.

Love It.

So what what some of the things that have been mentioned is and.

And your explanation right is that.

There are some quite a few restrictions to when you can actually use the DLC.

And there isn't really a mechanism or at least I've been told to say you know what the standard we really don't believe the standard is particularly this too is applicable to our particular product or there is some very specific reason right. So that is all a potential limitation. The other limitation as you were there was a question about the signing of the <unk>.

Norm.

And you mentioned there are some concerns surrounding that form right I think that language.

[Analyst 1]: I think that language of the attestation is viewed as quite prescriptive, right? You know, there's not really as much of a caveat as you see in certain other ones about To the best of your knowledge. I think that's also potentially an issue as well. The other thing that some people have mentioned to me, you know, I assume that these are isolated incidents, but we have heard some reports of is that even when there is a DOC, there may be a request for the entire test report and to examine the entire test report. Therefore, right, if there's a perception that even if you use a DOC, the entire test report will be requested, that there might be less of an inclination to use the DOC.

Substation is viewed as quite poor.

Prescriptive right and there is not really as much of a caveat as you see in certain other ones about to the best of your knowledge and I think that's also potentially an issue as well.

Other thing that some people have mentioned to me and I assume that these are isolated incidents, but we have heard some reports of is that even when there is a D. O C that there may be a request for the entire test report and to examine the entire test report and therefore right. If if if there is a <unk>.

<unk> that even if you use the DSC the entire test report will be requested that there might be less of an inclination to use the POC. So just some food for thought to start the discussion about some of the things that were reported to me.

[Analyst 1]: Just some food for thought to start the discussion about some of the things that were reported to me.

Scott Colburn: Sure. All right. Thank you, Jamie. Yeah, we know that, you know, and this is an area we really want to continue to work on, and so everyone here is gonna hear from us in different venues of how we can help use, you know, someone being comfortable in using that attestation, that Declaration of Conformity, and what are best ways that we can do it. I know there's two ways that we're trying to now approach this as well. While we usually think of the use of standards and premarket submissions, we know there is a litany of devices that don't go through the premarket process, or there's ways that you may use an updated standard or, you know, based upon changes to the device that may not constitute the need to submit.

Alright, Thank you Jamie and we know this is an area, we really want to continue to work on them. So everyone here is going to hear from us and from different venues, how we can help us.

Some of them being comfortable in using that attestation that declaration conformity and what our best ways that we can do it I know there's two ways that we're trying to now approaches as well, while we usually think of the use of standards and pre market submissions. We know there is a litany of devices that don't go through the pre market process for there is ways that you may use.

And updated standard or you know based upon.

Upon changes to the device that may not constitute the need to submit.

Scott Colburn: Maybe the standard itself is updated, and you've chosen to utilize the most current version. You know, a lot of those things may not come through a premarket submission, but how do you still maintain as part of your Device Master File and all the quality system documentations that you have as part of your, you know, on the risk management file, how do you make sure that you're demonstrating that you're in conformance with the standard? Are you using a Declaration of Conformity to do so, even in those venues where it's not accompanying maybe a premarket submission? We're looking at what are the differences that a premarket submission may have in it, versus what you may have just in a normal update to a file.

Scott Colburn: Maybe the standard itself is updated, and you've chosen to utilize the most current version. You know, a lot of those things may not come through a premarket submission, but how do you still maintain as part of your Device Master File and all the quality system documentations that you have as part of your, you, know, on the risk management file, how do you make sure that you're demonstrating that you're in conformance with the standard? Are you using a Declaration of Conformity to do so, even in those venues where it's not accompanying maybe a premarket submission? We're looking at what are the differences that a premarket submission may have in it, versus what you may have just in a normal update to a file.

Or maybe the standard itself is updated and you've chosen to utilize the most current version.

So a lot of those things may not come through a premarket submission was how do you still maintain as part of your device Master file and all the quality system Documentations that you have as part of your on the risk management for how do you make sure that you are demonstrating.

That you are in conformance with the standard and are you using a declaration confirming to do so even in those venues where it's not accompanying maybe a premarket submission.

So we're looking at what are the differences in a premarket submission may have versus what you may have just in our normal update to a file. So I think these are things that we want to continue on this there are people have other thoughts on that too and I appreciate it.

Scott Colburn: I think these are things that we wanna continue, and if there are people who have other thoughts on that too, we would appreciate it.

Yeah.

Terry Woods: Thank you, Scott.

Scott Colburn: Okay. Thank you.

Terry Woods: That's interesting about.

Scott Colburn: Okay. Thank you.

Terry Woods: That's interesting about.

Thank you Andrew.

Andrew that's interesting.

Scott Colburn: Yeah.

Terry Woods: you know, the exempt ones, so.

About.

Exempt ones.

Scott Colburn: Yeah, well, it's just, you know, there's a lot of products out there that use standards that don't necessarily submit, but, you know, if an inspection was to take place, how would you also be, you know, demonstrating that you're using that standard in accordance to how it was recognized or if you had to make the appropriate modification, you know, and what is that attestation of such as well? I think maybe we could go to the next. You wanna go to the next slide, person? Or we could maybe go to Zach or Zachary. Okay. There you are. I think you're live.

Well, it's just there's a lot of products out there that your standards I don't necessarily submit but from inspection with to take place. How would you be also steel demonstrating that youre using that standard and of course I was how it was.

Recognized or if you had to make the appropriate modification.

What does that attestation of such as well.

So I think maybe we could be better than you all go to the next slide person or.

We can maybe go to Zach was equity.

Yeah.

Mhm.

Or you are I think you're you're live.

Zachary Feller: Hi. Zachary Feller. I represent Linde, and I'm also part of the CGA, Compressed Gas Association. So I'm here really on their behalf, as a representative that couldn't attend. This is just trying to tie my first question that I had to your question, actually. One of the challenges that we have heard from our industry membership has been that because the listings on the website are actually out of date for our consensus standards, it's difficult for us to wanna use the declaration of conformity because we don't feel that if we do it to a current revision that it's going to be accepted. Because the version that you have posted is a later one.

Zachary Butler I represent Lindy and I'm also proud of the CGA compressed gas Association.

So I'm here really on their behalf.

Is that right.

10.

Really this is it.

Just trying to tie my first question.

That I had to your question actually.

One of the challenges that we have heard from our industry membership has been that because the listings on the website are actually out of date for our consensus standards.

It's difficult for us to want to use the declaration event.

Declaration of performance, because we don't feel that if we do it to a current revision that it's going to be accepted.

Because the version that you have posted.

Terry Woods: Zachary, I mean, one thing you could do is request that we consider the standards for recognition if for some reason we haven't recognized the most current version or the version that you think is, you know, the most representative. Contact us. There will be a website or an email address on the slide toward the end that. Just send us an email and request that we recognize, again, the most current versions of those documents.

A later one.

Zachary I mean, one thing you could do is requests.

The request that we consider the standards for recognition if for some reason we havent recognized the most current version or the person that you think is.

Is the most representative com.

Contact us there'll be a website or an E mail address on the slide towards the end that just send us an email and requests that we recognize.

Again, the most current versions of both documents.

Zachary Feller: We are preparing a request actually right now.

We are preparing a request actually right now we have a task force to review all of our standards and submit a request to recognize.

Terry Woods: Great.

Zachary Feller: We have a task force to review all of our standards and submit a request for recognition, so.

Scott Colburn: Yeah. No, thanks. Yeah, again, that's a great call for our, the ability. Anyone can request a recognition of a standard. We do try to be aware of the standards that are coming out as they do from a majority of the standard development organizations that we're engaged with. We're not involved in everything. While we do get, I think about 85% to 90% of standards that come through, there are certain areas that we're not necessarily as engaged with in the development of the standard.

Yeah. Thanks, Yeah, so and again Thats, a great call for or the ability anyone can request a recognition of a recognition of a standard.

We do try to be aware of the standards that are coming out as they do from a majority of the standard development organizations that were engaged with but we're not involved in everything and while we do yes.

I think about 85% 90% of standards that come through there are certain areas that were not necessarily as engaged with and the development of the standard. So if you do see a standard that is published that we recognize or whether you think there should be recognized.

Scott Colburn: If you do see a standard that is published that we recognize, or one that you think should be recognized, we do have that process that you can formally request recognition, or you could even just ping us if you think that was something that maybe we would have normally been recognized, but maybe it just didn't come up. Now, I would say, you know, give us a few months or so after a publication because we do work in cycles. You can always give us a heads-up that there's a newer standard that maybe you'd want us to consider in the next cycle, or you can do a formal request that we have outlined in our websites.

We do have that process that you confirm a request recognition or you could even just paying us. If you think that was something that maybe we would have normally.

Recognize that maybe it just didn't come up now I would say I'll give us a few months or so after a publication because we do work in cycles, but you can always give us a heads up that there is a new standard that maybe you'd want us to consider in the next cycle or you can do a formal requests that we have outlined on our websites.

Scott Colburn: Why don't we go to the next hand up as well, Tony, if we can do that one, and then we'll get a few. Tony, I think we're gonna try to get you going.

Yes.

Scott Colburn: Why don't we go to the next hand up as well, Tony, if we can do that one, and then we'll get a few. Tony, I think we're gonna try to get you going.

Why don't we go to the next hand up as well Tony if we can do that.

No.

So plenty of the Grand charter.

Dawn.

[Analyst 2]: Do you have me?

To help me.

Scott Colburn: Yes, we do.

Yes, we do.

Terry Woods: Yeah.

[Analyst 2]: Great. It's admittedly duplicative. I put it in the chat too. I was just wondering if you took a look at current circumstances in standards and in testing needed in support of medical devices, what percentage of that do you think could have a Declaration of Conformity that standards exist that have methods and acceptance criteria? In my experience, I feel like it's the vast minority, actually. But I have only the perspective that I have, so I was wondering what yours was.

Great. It's admittedly duplicative I put it in the chat too I was just wondering if you took a look at current.

Circumstances in standards and in testing needed in support of medical devices.

What percentage of that do you think could have a declaration of conformity that standards exist that have methods and acceptance criteria.

In my experience I feel like it's the the vast minority actually but.

Only the perspective that I have so I was wondering what yours was.

Scott Colburn: Yeah. No, that's a great we could hold an all-day debate probably too on trying to weigh what is a Declaration of Conformity to a standard that may not have, you know, either methods and/or acceptance criteria built in. Terry might have thoughts on this too. You know, I think the most important thing, and I'll go back to what I originally said, what a Declaration of Conformity is, it's a communication tool first and foremost saying, "This is the process that we are using, and we're using it in accordance with how you recognized it," which may also incorporate the use of some of the guidance documents that cite the use of those standards, even when it doesn't have the methods. Sometimes it doesn't have methods or it doesn't have acceptance criteria.

Yes.

Okay great.

If we could hold on all the debate, probably two or I'm trying to weigh in what is a declaration of conformity to a standard that may.

Not have either methods <unk> acceptance criteria built then and very matter of thoughts on this too but.

The most important thing and I'll go back to what I, originally said whether declaration performer, yes, it's a communication tool first and foremost, saying this is the process that we're using and we're using it in accordance with how you recognize too which may also incorporate the use of some of the guidance documents that site the use of those standards.

Even when it doesn't have the sometimes that doesn't have methods or it doesn't have acceptance criteria. That's the supporting documentation that you would need to provide to support your declaration of conformity and I feel thats still a stronger communication than just saving general use to a recognized standard when the review team may not have any.

Scott Colburn: That's the supporting documentation that you would need to provide to support your Declaration of Conformity. I feel that's still a stronger communication than just citing general use to a recognized standard when the review team may not have any advanced knowledge of, okay, you used this standard, but did you know, did you deviate from it outside of what the standard allows? That is an unknown factor which may require additional resources to do reviews. Consultations may also advance some additional information questions back for clarification. That's what we're trying to do, you know, if we can raise the understanding on how you communicate it to us, how you appropriately use the standard, that hopefully reduces some of the burden for us to then dig into how did you support the attestation of conformance.

Advanced knowledge of Okay, you use standard but did you.

Did you deviate from it outside of what the standard allow us and that is an unknown factor, which may require additional resources to do reviews of consultations may also advanced some additional information questions back for clarification.

And that's what we're trying to do is see if we can raise the understanding on how you communicated to us how you appropriately use the standard hopefully reduces some of the burden for us to then dig into how did your support.

The attestation of conformance so help.

Scott Colburn: Does that help a little bit?

[Analyst 2]: It does. If we did that, if you snapshotted right now, where do you think that would get us? Do you think it would get us to even 50% of the testing that's submitted that could be supported by a declaration? Again, my perspective is I think it's way less than that.

A little bit.

It does and if if we did that if you're a snapshot at right now where do you think that would get you think would get us to even 50% of the testing that submitted that could be supported by a declaration. So again my perspective is I think it's way less than that.

Terry Woods: You know, it's hard to say what fraction. I think part of the you know the beauty of the recognized standards is even when you've got a test method without an acceptance criterion, us recognizing it means that we have looked at that test method, and we believe that the method itself is you know has value, and we understand how that method is performed. So there is value to declaring conformity to a standard that has a test method but not acceptance criteria. You know, again, sometimes for horizontal standards, it may be hard to come up with acceptance criteria that are applicable across the whole range of devices for which that test method could be used. Again, the recognizing the test method means that we understand and we're in agreement that that's a reasonable way to do the test.

It's hard to say what fraction I think part of the beauty of the recognized standards is even when you've got a test method without an acceptance criterion.

US recognizing it means that we have looked at that test method and we believe that the method itself is you know it has value and we understand how that method has performed so there is value to <unk>.

Declaring conformity to a standard that has a test method, but not acceptance criteria.

Again, sometimes four horizontal standards it may be hard to come up with acceptance criteria that are applicable across a whole range of devices.

For which that test method could be used but again recognizing the test method means that we understand them and we are in agreement that that's a reasonable way to do the test and then you can give us the rationale for the specific acceptance criterion. I guess you can also think of it as kind of part of the evolution.

Terry Woods: You can give us the rationale for the specific acceptance criterion. I guess you can also think of it as kind of part of the evolution in the standards development process. You know, first we can recognize it with either the, you know, you've got the acceptance criterion or you've got the test method. As the SDOs or as we all work together within the SDO process to come up with additional generations of that standard, we work further and further and, you know, we can get closer to evolve it to have both test methods and acceptance criteria or to, you know, with each iteration, I think we work to make the standard more regulatory ready.

And the standards development process.

First we can recognize it with either that you thought the acceptance criteria are you've got the test method, but as the <unk> as we all work together within the FCO process to come up with.

Additional generations of that standard we work further and further and we can get closer to evolve it to have bulk test methods and acceptance criteria or two with each iteration I think we work to make the standard more regulatory ready so it's not just.

Terry Woods: It's not just a, you know, an on/off Declaration of Conformity with test method and acceptance criteria, but we can start with standards that we think are valuable and then keep working to make them more useful. It's, you know, again, it's part of that evolution or the total standards life cycle that we were talking about.

And on a declaration of conformity with with test method and acceptance criteria, but we can start with standards that we think are valuable in and keep working to make them more useful.

Again, it's part of that that evolution or the total standards lifecycle that we were talking about.

Scott Colburn: Thank you, Terri. Mike, great question. All right, I think we'll try to maybe get into some of the questions that have been brought in then. Some of these are a little repetitious, so we may skip over a couple of them if we felt like we've hit them. I wanna see. I see a lot of different questions regarding either transition or when there's a new standard that's been revised, but not yet recognized by the FDA, but the company may have already complied with it. In this situation, what does FDA recommend to do? Should you use the FDA recognized standard number from the older revisions? Specifically that situation, you would only cite a recognized standard in the current edition of to which it's being recognized.

Scott Colburn: Thank you, Terry. Mike, great question. All right, I think we'll try to maybe get into some of the questions that have been brought in then. Some of these are a little repetitious, so we may skip over a couple of them if we felt like we've hit them. I wanna see. I see a lot of different questions regarding either transition or when there's a new standard that's been revised, but not yet recognized by the FDA, but the company may have already complied with it. In this situation, what does FDA recommend to do? Should you use the FDA recognized standard number from the older revisions? Specifically that situation, you would only cite a recognized standard in the current edition of to which it's being recognized.

Thank you Sir.

Great question.

Alright, So I think we'll try to maybe get into some of the questions that have been brought in and some of these are little repetitious. So we may skip over a couple of them just we felt like we've set them.

So I wanted to see I see a lot of different questions regarding either transition or when there's a new standard that's been revised but not yet recognized.

And by the FDA, but the company may have already complied with it and in this situation where does FDA recommended to do.

Should he has the FDA recognized standards number from the older revisions.

So just specifically.

Typically that situation.

You would only cite a recognized standard in the current addition to which it is being recognized a newer version may have additional.

Scott Colburn: A newer version may have additional, considerations or parts of the scope, so we don't want to put a new one in place before it is recognized. We wanna make sure you're citing the recognition number with the version of the standard that you're using. If you have a newer version that you feel strongly about and you don't see it recognized, you could always, again, request recognition, or ask, you know, the review team if you want to also, what their thoughts would be on that. Again, we try to stay as current as we can with recognitions, but also know that changing from one version to the other version needs to be a little more transparent, and we need to take into account the burden of switching versions of a standard.

Considerations or parts of the scope. So we don't want to put a new one in place before it is recognized you want to make sure you're citing the recognition number with the version of the standard that Youre using.

If you have a newer version that you feel strongly about and you don't see it recognize you could always again request recognition.

Or ask you all to review team if you want to also of what their thoughts with beyond that again.

Again, we tried to stay.

As current as we can with recognitions.

But also know that changing from one version to the other version needs to be a little more transparent and we need to take into account the.

Burden of switching versions of a standard so in many cases when you see a newer version you'll see a transition date and this answers a few other questions that are in the portal as well and our transition date is intended to communicate that we are recognizing for a period of time both versions, while the one that's been Superceded times out.

Scott Colburn: In many cases, when you see a newer version, you'll see a transition date, and this answers a few other questions that are in the portal as well. Our transition date is intended to communicate that we are recognizing for a period of time both versions while the one that's being superseded times out. You may see a transition time for a particular standard for one year or two years or maybe three years. What goes into that consideration is what do we feel the impact on the newer version of that standard would have on someone being able to utilize that appropriately in a coming submission. In terms of how you cite that standard, though, we know that sometimes you do testing, and then it's getting close to the end of that time.

So you may see a transition time for a particular standard for one year or two years or maybe three years and what goes into that consideration is what we feel the impact on the newer version of that standard would have on someone being able to utilize that appropriately and are coming submission.

In terms of how you cite that standard, though we know that sometimes you do testing them then it's getting close to the end of that time.

Scott Colburn: The important thing is that in your submission, if you have testing in a standard that was conducted while it was still recognized, but when you maybe submitted or during the course of the review, it actually transitioned out, you can still utilize that older version of that standard for the Declaration of Conformity if you demonstrate that testing was done while it was still recognized. There are ways to do it, but, you know, as always, never, you know, hesitate to contact someone at the agency to help answer that question as well. Another one maybe you want to hit, Terry?

The important thing is that in your in your submission. If you have testing in a standard that was conducted while it was still recognized but when you may be submitted during the course of the review it actually transitioned out you can still utilize that older version of that standard for the declaration conformity. If you demonstrate that testing was done while it was still recognized.

So there are ways to do it but as always never hesitate to contact someone at the agency to help answer that question as well.

So maybe you want to hit.

Terry Woods: Um.

Hum.

Scott Colburn: I know there was one, see. Kevin had. Let me see here.

And then there was one see Taiwan.

Okay.

Yeah.

Terry Woods: Sorry. Yeah, we're searching through the questions here.

So here is a trend I'm sorry, yes.

We're searching through the questions here.

Okay.

Yes.

Scott Colburn: There's one by, I'm assuming one of our SDOs. What can SDOs do to help expedite the recognition of standards and any advice on new technologies such as AI and getting acceptance by FDA? Maybe we can take that in two parts. Anytime, Sharon, I think this is your question, we can, you know, communicate with each other on standards that would come up, especially in SDOs that have mirror committees to other international groups, or possibly we do not have, you know, FDA or other regulatory presence, that might come into that situation that we don't know until after the fact.

So it was won by our partners.

And that was seen in one of our Sto as Watson Stl's due to help expedite the recognition of standards in any advice on new technologies, such as AI and getting acceptance by FDA.

So maybe we can take that in two parts.

So anytime.

And I think this is your question we can.

Communicate with each other on standards that would come up, especially U sto as that have near committees to other international groups or possibly we do not have ft.

FDA or other regulatory presence.

That might come into that situation that we don't know until after the fact, so working with stakeholders, whether its at the national level and I'm kind of speaking to this on an international.

Scott Colburn: Working with stakeholders, whether it's at the national level, and I'm kind of speaking to this on a, an international podium here, but anytime you're working with stakeholders and you're looking at your table of people developing the consensus document, if you don't have a stakeholder present, there's a good chance that stakeholder may not be aware of the standard being developed. Trying to get them early into the development cycle of the standard is critical. That's whether it's at the national level or at an international level. I think it's important to have the right type of stakeholder.

Odium here, but anytime youre working with stakeholders and Youre looking at your tables, but people developing a consensus document. If you don't have a stakeholder present, there's a good chance that that stakeholder may not be aware of the standard being developed so trying to get them early into the probe into the development cycle of a standard is critical and Thats.

Whether it's at the national level or at an international level I think it's important to have the right type of stakeholder.

Scott Colburn: Working with the stakeholders, in this case regulators, early on would help not just expedite the recognition of standard, but also help that standard become what's called regulatory-ready or regulatory grade, which is an area where we look at how do those standards help meet the needs of what FDA and other regulators are looking at to help support the appropriate use of that standard towards whatever the intention is from the scope. Having involvement is very important.

And then working with the stakeholders in this case regulators early on would help.

Not just expedite the recognition of standard but it also helped that standard become what's called regulatory ready a regulatory grade, which is an area, where we looked at how do those standards help meet the needs of what FDA and other regulators are looking at to help support the appropriate use of that standard towards whatever the intention is from the scope.

So having involvement is very important there are many regulators have very limited resources and budget to be able to collaborate but I think it's important to find whichever way is feasible to do that to enhance the opportunity for regulators to communicate early into that standard to optimize it's used for regulatory purposes.

Scott Colburn: Now many regulators have very limited resources and budget to be able to collaborate, but I think it's important to find whichever way is feasible to do that to enhance the opportunity for regulators to communicate early into that standard to optimize its use for regulatory purposes once it is published and hopefully recognized by regardless of the jurisdiction. The second one, maybe Terry, you could take on advice on new technologies too, on how does FDA, how do we look at that? How do we look at it from an acceptance point of view?

It is published and hopefully recognized by regardless of the jurisdiction.

The second one maybe you could take on advice on new technologies to them, how does FDA, how do we look at that how do we looked at it from an acceptance point of view.

Terry Woods: Well, I think, you know, again, for the new technologies, they're trickier to write standards because they're, by their nature, new technologies. I think if, you know, if there's a group that comes to an SDO and is willing to write a standard, then that's something that we could absolutely, you know, you could submit to us for consideration for recognition. Again, you know, once the individual device community has decided that there's a need for a standard, then, we're more than willing to take a look at that published standard and see if it's something that we think could be recognized.

Well I think again for the new technologies.

They are trickier to write standards because they are by their nature of new technologies, but I think if if.

If there is a group that comes to an sto and is willing to write a standard.

Then that's something that we said absolutely you could submit to us for consideration for recognition again.

Once the individual device community has decided that there is a need for a standard then.

We're more than willing to take a look at that publishing it and see if that's.

If it's something that we think.

Could be recognized.

Scott Colburn: I think there's a couple other ways too that we can look at this. One is, we'll use artificial intelligence and machine learning as an example. We know that there are several SDOs working at both the national, international, and regional areas on this. We know that there are a number of different departments within, say, the federal government that are coordinating on this approach. But we are trying to do that. That's it. In fact, we are trying to coordinate. There are specific activities that we're trying to do in conjunction with other agencies within the department, and with other departments across the federal government.

There's a couple of other ways too early to look at this one is unusually and they will use artificial intelligence and machine learning as an example, we know that there are several STR was working at both the national and international and regional areas on this.

And we know that there are a number of different departments within the federal government that are coordinating.

On this approach, but we are trying to do that in fact, we are trying to coordinate there are specific activities that we're trying to do in conjunction with other agencies within the department and with other departments across the federal government. In addition, we're trying to work with other regional and global regulatory groups like the <unk>.

Scott Colburn: In addition, we're trying to work within other regional and global regulatory groups like the IMDRF and Global Harmonization Working Party, for example, on how can we develop a solid regulatory voice on some of these newer technologies to help the early advancement of some of this into standards. The earlier we get engaged on trying to help in those things, the better it is for a standard to have some acceptance abilities in the when they publish, and hopefully then we can help fold those into how we would address that for recognition. Maybe what we can do is go into, you know-

Amortization working party for example on how can we develop a solid regulatory voice on some of these newer technologies to help the early advancement of some of this into standards. The earlier, we get engaged on trying to help in those things the better. It is for a standard to have some acceptance abilities and when they are.

Publish and hopefully then we can help before goes into how we would address that for recognition.

But maybe what we can do is going to no question to see if what we have for question two and see if some of our comments go into that.

Terry Woods: Question two.

Scott Colburn: See if what we have for question two and see if some of our comments go into that. We're trying to monitor. We have a lot of comments, and then we have another thing. What we're trying to do here, this is a little bit more of what do you think we can do to make it easier for medical device submitters to include the correct supplemental documentation for the standards they cite? How can we make it easier for manufacturers to identify and submit the correct supplemental documentation? We'll look for some newer comments that maybe can come and ask us, provide or feel free to raise your hand if you wanna make a few comments.

We're trying to monitor we have a lot of comments and then we have another thing, but what we're trying to do here. So this is a little bit more what do you think we can do to make it easier for medical device Submitters to include the correct supplemental documentation for the standards. They cite how can we make it easier for manufacturers to identify and submit the correct supplemental documentation.

Yeah.

So we'll look for some newer comments that may be can come and ask us provide or feel free to raise your hand, if you want to make a few comments.

Scott Colburn: One of the things we do know that we are trying to work on is how our Supplemental Information Sheet is it, first of all, clear? Can we identify a little bit more within a standard, how it promotes itself towards the use of a Declaration of Conformity? That is something that we're looking to try to do. As I mentioned earlier, our Supplemental Information Sheets are not guidance documents, so there is a very, you know, finite limitation on what we're able to communicate through there. That kind of goes back into what I said earlier about making sure how does the standard communicate its appropriate use towards, the types of information that's necessary to support the standard itself, and then can we work a little bit further?

One of the things we do know that we are trying to work on is how our supplementary information can sheet is.

Is it first of all clear.

And can we identify a little bit more within our standard Howard.

Promotes itself towards the use of a declaration conformity and that is something that we're looking to try to do but as I mentioned earlier, our supplementary information sheets are not guidance documents. So there is a very.

<unk> limitation on what we're able to communicate through there so that kind of goes back to what I said earlier about making sure how does the standard communicate it's appropriate use towards.

The types of information thats necessary to support.

The standard itself and then can we work a little bit further and this can be done through a number of different ways methods ISO IC standard, but were unable to build that into that construct could it be done through a national adoption.

Scott Colburn: This can be done through a number of different ways. If it's a ISO or IEC standard, but we're unable to build that into that construct, could it be done through a national adoption process, or can we find other ways that we can build into that? Early thinking about this early in the earliest stages, I think is also what can help us build the possibility of making standards stronger in terms of how they communicate their appropriate use and getting the right type of supplemental documentation. FDA also tries to help this by utilizing some guidance documents, and I think a good example is the human factors guidance document.

Process or can we find other ways that we can build into that.

Early thinking about this early in the earliest stages I think is also what's and help us build the possibility of making standard stronger and towards of how they communicate.

Their appropriate use and getting the right type of supplemental documentation.

FDA also tries to help this by utilizing some guidance documents and I think a good example is the human factors guidance document the human factor standard itself as you know.

Scott Colburn: The human factors standard itself is, you know, a very hard one to say, "Yeah, we recognize that, but how would you declare conformity to it when it uses risk management and many other facets, and asks, you know, for usability studies and the protocols?" It'd be really hard to try to guess what you need to supply as that information. FDA wrote a guidance document that specifies what is the information that we need in a human factors study, and that's how we apply that into the recognition of the standard. I believe that approach is very similar to what we have from a few other questions too, in areas like biocompatibility, for example, or other types of guidances we've published, where standards are a part of that.

Very hard one to say, yeah, we recognize that but how would you declare conformity to open that uses risk management and many other facets and asks for.

Usability studies and the protocols.

It would be really hard to try to guess what do you need to supply as that information. So FDA wrote a guidance document that in their sites. What is the information that we need in the human factor study and Thats, how we apply that into the recognition of the standard and I believe that approach is very similar to what we have from a few other questions too in areas like <unk>.

Profitability for example, or other types of those types of guidance as we published.

Where standards are a part of that we do try to make sure that we tie that in as close to the standard.

Scott Colburn: We do try to make sure that we tie that in as close to the standard as possible to help direct our manufacturers what would be the approach in which you would convey that, the documentation to support the standard as recognized. Terry, do you have thoughts on anything?

As possible to help direct our manufacturers what would be the approach in which you would convey that documentation to support the <unk>.

Standard is recognized.

Clarity of subs.

Okay.

Terry Woods: Let's see. I guess I'm looking at one question just to clarify. Someone's asking if a standard isn't recognized by FDA but a company's used it, does FDA want us to add it to the DoC or not? No, the declarations of conformity are only for recognized standards. You can use any standard that you want in your device submission, but you only include a declaration of conformity to recognized standards. Standards that aren't recognized, again, you use, but you don't declare conformity to them. I guess someone else also asked, where do you find the SIS sheets? Again, in a later slide, we'll have a link to our recognized standards database. When you click an individual standard in that database, the supplemental information sheet will pop up with that.

Okay, I guess I'm looking at one question just to.

Clarify.

Someone was asking if a standard isn't recognized by FDA that accompanies used it does FDA wants to add it to the GSE or not.

The declarations of conformity are only recognized units. So you can use any standard that you want in your device submission, but youre only.

Include a declaration of conformity to recognize standards.

Standards that arent recognized again, you used a chunk declare conformity to them.

Okay.

As someone else also asked where do you find the Fas sheets.

Again at the latest five will have a link to a revenue recognized standards database.

When you click on individual standard in that database.

The supplemental information sheet will pop up with that.

Okay.

Scott Colburn: All right. I think we'll take one here that kind of hits a little bit about declarations of conformity, and it says to advance the use of declarations of conformity to our recognized standards, alignment with EU standards would be helpful. You know, for EU manufacturers are required to keep the product state-of-the-art, but in the US, the standards are usually older. Manufacturers usually test to the latest standard to stay compliant with the EU, so the declaration of conformity is not usually used in US submissions. I found that very interesting too, because our understanding is that the EU does not have very many standards in its that it recognizes currently. We do try to make sure we maintain the most recent version of a standard recognized within a couple months of it coming out.

So I think we'll take one here that kind of hits, a little bit about declarations conformity and it says.

To advance the use of decorations conformity to our recognized standards alignment with EU standards would be helpful. For you manufacturers are required to keep the products state of the art in the U S. The standards are usually older manufacturers, usually test of the latest standards to stay compliant with the EU. So the declaration for two.

Memory is not usually used in U S submissions.

I found that very interesting too because our understanding is that the <unk> does not have very many standards and its rectum.

Recognizes.

Currently.

And we do try to make sure we maintain the most recent version of our standard recognized within a couple of months of it coming out.

Scott Colburn: That said, years ago, we used to be told that we're recognizing standards too quick, and the older version is something that needs to stay recognized. That's why we have the older and newer versions recognized for a period of time, sometimes up to three years, even more as circumstances dictate that need. That said, if there are newer standards that have been published and that we are not yet recognizing, we would appreciate knowing. Typically EU standards we don't see recognized in our database, unless they are independently individual standards that are not in an ISO, IEC, or other US or other international organization. Because we know many of the EU standards are those that went through some sort of agreement and became an EU standard from the ISO or IEC adoption process.

But that said.

Years ago, we used to be told that we're recognizing standards to click and the older version is something that needs to stay recognize so that's why we have the older and newer versions recognized for a period of time, sometimes up to three years, even more as circumstances dictate that need.

That said if there are newer standards that have been published and that we are not yet recognizing we would appreciate knowing tip.

Typically he was standards, we don't see recognized in our database.

Unless they are independently.

Individuals standards that are not in an ISO ISC or other U S U S or other international organization.

Because we know many of the U S standards are those that went through some sort of agreement and became an end.

And he is standard from the ISO or IC adoption process for example, with <unk>.

Scott Colburn: For example, with CEN, CENELEC. What we wanna do is make sure, you know, I wanna make sure we understand the issue, but if there are standards that you don't see us recognize, I think Terry mentioned it earlier too. We do have a portal for you to request for recognition, and we'll take that into account responding. Here's another one. Got a few more questions. Someone asked a question about Form FDA 3514 again, and whether something is not recognized, would you include it in 3514? The answer is yes. If it is not recognized, if you cite it in there, I think that's still very helpful to the reviewer as well as to our program to know what standards are being utilized that may not be recognized.

So what we want to do is make sure.

I want to make sure we understand the issue, but if there are standards that you don't see us recognize I think Terry mentioned earlier too we do have a portal for you to request for recognition and we will take that into accomplish socket.

Okay.

One of them.

Two more questions.

Yeah.

Yes.

So someone asked a question about $435 14, again and whether something is Rex did not recognized would you included $35 14 and answer is yes.

And if it does not recognize if you cited in there I think thats still very helpful to the reviewer as wells to our program to know what standards are being utilized that may not be recognized you just wouldn't be supporting that through a declaration of conformity and you'd be citing general use and platform.

Scott Colburn: You just wouldn't be supporting that through a Declaration of Conformity, and you would be citing general use in that form. What you got, Terry?

Yeah.

Okay.

You got Terry.

Terry Woods: Let's see. Someone said, "You should communicate with us on questions around standards. What are the easiest ways to connect with us? Do we need a full-fledged meeting, or can you send us emails?" You know, again, that depends a little bit on what it is that you're trying to ask. If it's a more general question, not about a specific device application, then you can send our standards email address a question, and we will try to get back to you. Or you can, again, we can see if it's something that needs to be a conversation or something that we can address by email. If it's a question about specific standards to be used in a specific device application, then you need to go to the review team that's working on that specific device.

As Tom said.

You say that communicate without some questions around standards, what are the easiest ways to connect with us.

Do we need of a whole bunch meeting or can you send us E mails and that depends a little bit on what it is that youre trying to ask if it's if it's a more general question.

Not about a specific device application then you can send our standards.

E Mail address a question and we will try to get back to you or you can again, we can see if that's something that needs to be a conversation or something that we can that we can address by E mail.

It's a question about specific standards to be used in a specific device application and you need to go to the review team that's working on that specific device.

Scott Colburn: Okay. I think what I'm gonna do is I'm gonna read the third question, but then go from some of the current comments, but that way people keep filtering in some newer comments if they want. If we go to the third question, it asks, you know, "We'd like to know what tools and other resources manufacturers need to encourage the appropriate use of standards and submission, and what would you find most helpful?" Kind of looking at what other tools and resources could be developed, not necessarily by FDA as well, but, you know, what could we do through any number of other networks that we could have in building this.

Okay.

So I think I'm gonna do is I'm going to read the third question, but then.

Some of the current comments were that way people keep filter in in some newer comments if they want.

And if we go to the third question.

Asks.

We'd like to know what tools and other resources manufacturers need to encourage the appropriate standards and submission and what would you find most helpful.

So kind of looking at what other tools and resources to be developed not necessarily by FDA as well, but what can we do through any number of other networks that we can have in building this and actually that's my preferences that we try to work with our public private.

Scott Colburn: That's my preference is that we try to work with our, you know, through that public-private partnership, working with SDOs or other organizations in developing the tools I think can be used more broadly, you know, with other regulators, with other agencies, rather than something that is, you know, just coming out of the FDA. We do have an example. It kinda comes from a recent comment on, is there ways that we can get examples of declarations of conformity?

Partnership or <unk> or other organizations and developing the tools that they can be used more broadly.

With other regulators with other agencies, rather than something that is just coming out of the FDA.

We do have an example in that kind of comes from a recent comment on.

What are <unk>.

There are ways that we can get examples of declarations of conformity and I think that is one of the things we are striving to try to do but we need your help in doing that as well to ensure that we are doing something that would not just worked at FCA, but work in the jurisdictions that you may be needing to use that declaration, four or which could be in the U S or our external.

Scott Colburn: I think that is one of the things we are striving to try to do, but we need your help in doing that as well to ensure that we are doing something that would not just work at FDA, but work in the jurisdictions that you may be needing to use that declaration for or, you know, which could be in the US or external. But, you know, one person asked about, you know, our example that we provided about the ASCA program, the Accreditation Scheme for Conformity Assessment. On our website, if you go to the ASCA website and click on either of the two program-specific guidances for basic safety, essential performance, or biocompatibility, or it might be titled biological evaluation under the ASCA program.

But the.

One person asked about our example that we provided about Africa program. The accreditation scheme for conformity assessment and on our website. If you go to the Aster website and clicked on either of the two programs specific guidance as for basic safety essential performance or biocompatibility.

Biological valuation under the Aska program towards the end, we actually provide an example of a declaration of conformity.

Scott Colburn: Towards the end, we actually provide an example of a Declaration of Conformity and the summary test report. Now, realize that those summary test reports are specific to how that standard would be utilized under the ASCA program. It does provide an insight to what we were looking at. In getting to the summary test report, which may be different than the supplemental documentation or supporting documentation you need for a Declaration of Conformity, realize that the summary test report is based upon our knowledge already of knowing those testing laboratories included in the program and the confidence that we have in understanding their competence in testing and how they approach that as an organization.

And the summer Test report.

All lines that those summer test reports are specific to how the that standard will be utilized under the <unk> program, but it does provide an insight to what we were looking at.

And getting to the summary test report, which may be different than the supplemental documentation of supporting documentation you need for a declaration conformity realized that the.

Summary test report is based upon our knowledge already of knowing those stand those testing laboratories included in the program and the confidence that we have an understanding their competence in testing and how they approach that as a as an organization. So our concerns questions usually are alleviated already by having that relationship.

Scott Colburn: Our concerns or questions usually are alleviated already by having that relationship, so we are looking at a minimum amount of information to help support the Declaration of Conformity with the knowledge of already understanding that laboratory a little more. Applying this to the other almost 1,400 standards in the program that aren't in ASCA, we do wanna take an approach of looking at how can we communicate better what goes into a Declaration of Conformity, but most importantly, what goes into that supporting documentation for the Declaration of Conformity. That kinda goes back into working with our standards development organizations first to see if tools can be developed there, or seeing if there's other ways that we could enhance existing guidances that we have.

So we are looking at a minimum amount of information to help support the declaration in conformity with the knowledge of already understanding that laboratory a little more.

Applying this to the other almost 1400 standards in the program that aren't in Africa.

We do want to take an approach of looking at how can we communicate better what goes into a declaration of conformity, but most importantly, what goes into that supporting documentation.

For the declaration of conformity and that kind of goes back into working with our standard developing organizations first to see if tools can be developed there.

Or seeing if theres other ways that we could enhance existing guidance is that we have our hope is to build with.

Scott Colburn: Our hope is to build with the communications that we get from this workshop and future discussions, ideas on what we could do to enhance that from a higher level. To be able to do it across all the different standards would really be best suited when we work together on that approach within the organizations that develop the standards. Terri, I don't know if you have other thoughts on that. Now I put you on the spot.

With the communications that we get from this workshop in future discussions ideas on what we can do to enhance that from a higher higher level, but to be able to do it across all the different standards would really be best suited when we worked together on that approach within the organizations at double standards and.

Terry I don't know if you have other thoughts on that.

Terry Woods: I think that pretty much covers it. I guess, going to another comment, someone said, "As a regulatory professional, one of the things I remember needing most earlier in my career are examples of DSCSA and also the information to be included in summaries of reports when those are needed to be submitted. Does general industry have access to the examples from the ASCA program, and if so, where can we find them?" Yes, anyone has access to the ASCA information. We have, again, if you look at the slides after the program is over with, there's a slide on ASCA resources that has links to all of the ASCA information, and we encourage you all to take a look at that.

No questions Bart.

Pretty much.

Yeah.

Yes.

Going to another comment.

Someone said is a regulatory professional and one of the things I remember meeting most earlier in my career examples of DSC and also have the information to be included in summary separate reports when those are needed to be submitted does general industry have access to the examples from May ask a program and if so where can we find them.

Yeah anyone has access to the ask of information we have again, if you look at the slides to add after the program is aware there is a slide on Astral resources that has links to on all of the ask that information and we encourage you all to take a look at that.

Yes.

Okay.

Scott Colburn: All right. So someone did list, "It would be helpful, for example, on the Recognized Consensus Standards database to provide a list of the submissions that have been cleared or approved utilizing the standards in that database, include recognized consensus status used as part of design submission." I'm not too sure if I fully understand that. I mean, first I think that would be, I mean, it would be very interesting to see, you know, a way for especially trying to select a, product kit or something, knowing what others have been cleared using that. There are a couple ways that someone can navigate, though, to understand what types of standards would be applicable.

Okay.

Right.

So someone did list it would be helpful. For example on a recognition database right. A list of the submissions that are being cleared or approved utilizing standards and that in that database.

Could recognize consortium centers as part of designs submission.

Not too sure if I fully understand that I mean, first I think that would be I mean.

Very interesting to see.

For especially trying to select a private kit or something knowing what others have been cleared using that.

There are a couple ways that someone can navigate though doesn't understand what types of standards would be applicable and a recognition database. We do try to cite the appropriate regulation and even product code for vertical based standards that are associated.

Scott Colburn: In our recognition database, we do try to cite the appropriate regulation and even product code for vertical-based standards that are, you know, associated in their scope to a particular type of device or device family. For horizontal standards like sterilization and software and, you know, risk management and biocompatibility, et cetera, many material standards, those are horizontal standards that we don't necessarily assign to a particular device area because they could apply to thousands and thousands. In reference to tying them to known or previously cleared submissions, that would be an extraordinary lift because those databases, you know, to be able to monitor that.

Associated in their scope to a particular type of device or device family for horizontal standards like sterilization and software and risk management, and biocompatibility et cetera. Many materials standards. Those are horizontal standards that we don't necessarily assigned to a particular device area because they put applied to thousands and thousands.

In reference to time them to known previously cleared submissions.

That would be an extraordinarily lift because those databases they ought to be able to monitor that and I think too there are certain levels of information that wouldn't be appropriate to share in that aspect, but I would say that when you are looking at credit kits any predicates do have a summary, a five 10-K summary that may lift the type.

Scott Colburn: I think too, there are certain levels of information that wouldn't be appropriate to share in that aspect. But I would say that when you're looking at predicates, many predicates do have a summary, a 510(k) summary that may list the types of standards that were utilized in their clearance for that approach. And that is a very helpful tool, I think, if you were looking to try to do a substantial equivalence designation, you would see it put in a summary 510(k) summary, possibly the standards that were utilized. Maybe those standards have since been updated if it is a clearance from a couple years ago, but it would point you in the right direction, and we would be able to do that as well.

Standards that were utilized in there.

Clearance for that approach.

And that is a very helpful tool I think if you were looking to try to do a substantial equivalence designation you would see it put in a summary.

I think a summary, possibly the standards every utilized maybe those standards have since been updated if it is.

Clearance from a couple of years ago, but at what point you into that right direction, and we would be able to do that as well.

Scott Colburn: Another thing we're trying to do from a historical standpoint, let's say a standard was superseded by a newer version, and I'll use ISO 594-1 and -2, which is the Luer standard, which has been superseded by the ISO 80369-7. I think at the end of 2023, the 594 standard would no longer be recognized.

Another thing we're trying to do from a historical standpoint, let's say a standard was.

Superseded by a newer version and I'll use ISO $5 94 Dash, one index to which the lower standard which has been superceded by the ISO eight O 369 seven.

I think at the end of 2023 of the 594 standard would no longer be recognized.

Scott Colburn: We are looking to see, is it possible or would it be helpful if we were to consider adding a historical reference in the Supplemental Information Sheet to previous versions of standards that were recognized in the past to help provide a historical lineage, so to speak, of understanding if you had an older predicate you're using that used an older standard, but that standard no longer exists and was superseded by a different version. Would that newer version be helpful to have in the Supplemental Information Sheet? That is a concept we are looking to see if that would be possible to help those who are looking to, you know, that come across that type of situation. Who do we have next?

But we are looking to see is it possible or would it be helpful. If we were to consider adding.

Historical reference in the supplementary information sheet to previous versions of standards that were recognized in the past to help provide a historical lineage. So to speak of understanding if you had an older productivity you're using that used in older standard, but that standard no longer exists and with superseded by a different version.

With that newer version.

Would that would be helpful to have in the supplementary information sheet and that is.

Concept, we are looking to see if that would be possible to help.

Those were looking into that.

That come across that type of situation.

Thanks.

Terry Woods: Let's see. We have someone asking if a device is marketed based on an approved standard-based FDA submission, does the change of a standard version require resubmission? No. Once your 510(k) has been cleared or your PMA approved, the device is legally marketed, and you don't have to redo testing just because the standard has been updated. If you make a modification to the device and do a new submission, then you need to look at the new version of the standard and consider whether or not the change requires you to repeat that testing.

Let's see we have a.

Someone asking if the devices marketed based on crude.

Standard based FDA submission does that change at the standard version acquired Resubmission now once your you're five 10-K has been cleared over here.

CMA approved.

The device is.

Legally marketed in you don't have to redo testing Jesse has sustainable SNF data, if you make a modification to the device and do any submission and you need to look at the new version of the standard and in consider whether or not a change.

Sorry to repeat that testing.

Scott Colburn: I'm gonna throw a different curveball onto that too, though, and say, you know, so in our appropriate guidance, we do talk about what happens when the standards change. Do I need to first use that newer version? And if so, do I need to resubmit? There's a couple things that you should always be looking at. One is, you know, if you're trying to figure out, do I need to submit based upon the change to a medical device, we have guidance on that, and it walks you through what would be the trigger that would indicate that maybe you should resubmit. Then to Terry's point, you would wanna make sure you're using the relevant standards.

Throw a different curve ball onto that to the uncertainty of what's happening in our appropriate guidance could you talk about what happens when.

Standards change do I need to first use that newer version and if so do I need to resubmit.

And Theres a couple of things that you should always be looking at one is trying to figure out do I need to submit based on the change to a medical device, we have guidance on that and it walks you through what would be the trigger that would indicate that maybe you should resubmit and then to Terry's point, you would want to make sure you're using the relevant standards, but every every medical device habits.

Scott Colburn: You know, every medical device has its life cycle, and part of our initiatives with the Total Product Life Cycle is looking at, you know, what happens, you know, over the years of your device. You're collecting information. You're using your risk management tool to determine, you know, potential changes. You're gonna see new test methods coming out that maybe would help describe what you're trying to understand with your device's performance. That's all part of how you operate in your quality system as well. I think if you know, are questioning, you know, do I need to use this new standard? I think you have to work with your organization in totality and look at what are we doing from a quality system standpoint?

<unk> has its lifecycle and part of our initiatives with the total product lifecycle is looking at what happens over the years of your device you're collecting information you're using your risk management tool to.

To determine any potential changes.

Going to see new test methods coming out that maybe would help describe what youre trying to understand what's your device performance and Thats all part of how you operate and your quality system as well. So I think if you know are questioning do I need to use the standard I think you have to work with your organization in totality and looked at what are we doing from a party assist.

Scott Colburn: How are we assessing the risks based upon newer information that's coming in, the real-world evidence that we're getting? Does that speak for us to need to consider testing to the newer standard? Based upon, you know, that will then help you answer that question. You know, from always looking at your product and seeing if you need to make changes to an already cleared medical device, following that guidance on when to submit would help you indicate whether you would need to have that in a submission that comes forward.

<unk> standpoint are we assessing the risks based upon newer information that's coming in the real world evidence that we're getting and does that speak for us to need to consider.

Testing through the newer standard based upon that that will then help you answer that question and then from I was looking at your product and seen if you need to make changes to an already cleared medical device following that guidance on when the submit would help you indicate whether you would need to have.

That in a submission that comes forward, but to Terry's point. Once you have a five 10-K, that's clear just because a new standard comes out doesn't mean, firstly you have to retest steroid and our rules or have to submit notify us of that and that 5% cable homes.

Scott Colburn: To Terry's point, once you have a 510(k) that's clear, just 'cause a new standard comes out doesn't mean, first, that you have to retest to it in our rules or have to submit and notify us of that in that 510(k) world. Okay.

Right.

Terry Woods: Let's see. We did have a comment suggesting in the SIS for a particular standard, recognized standard, it would be helpful if there was actually a link to the guidance documents that would be associated with that standard. That's definitely something we can take into consideration. We list the relevant guidance documents, but you're right, it would be easier to be able to then just click the link to the guidance document and get there. That's something that we'll definitely consider in our thoughts of how to make the SIS sheets more helpful to people.

Okay.

Let's see we did have a comment suggesting in the SaaS or particular standard recognized standards.

It would be helpful. If there was actually a link to the guidance documents that will be associated with that standard and that's definitely something we can take into consideration this development guidance documents.

You're right it would be easier to us to be able to then just click the link to the guidance after when you get there.

And that's something that we'll definitely consider in our.

In our thoughts of how to make the S. I S sheets kind of helpful to people.

Scott Colburn: All right. We have a hand raised. Jamie's hand raised again. I know we go live.

Okay.

Oh.

We have a handwritten genius Andres again, why don't we go lives yes.

Terry Woods: Yes.

Scott Colburn: Again, if anyone wants to ask a question or provide some comment, actually, is what we want here. Feel free to use the hand raise function.

He wants to ask a question or provide some comments actually is what we want here for 30 years the hamburgers function.

[Analyst 1]: I'm back. Hello to you two. This is such a fun discussion. Just to follow up on the discussion regarding the SIS, right? First of all, I really like the idea that you just provided about putting in some of the historical information, which I think is consistent with the recommendation I'm about to make of as much information as you can provide in the SIS as possible. You know, that historical information, particularly with the example, you know, of 80369 versus 594, number changes, right? You wouldn't necessarily think to look for that if you don't have the history. I think I like that idea as well as the idea we just heard from someone in the audience about, you know, actually having the link there. It's, you know, just one less step.

I'm back.

Hello to you David This is touch upon discussion.

So just to follow up on the discussion regarding the <unk>. So first of all I really like the idea that you just provided about.

Putting in some of the historical information, which I think is consistent with the recommendation I'm about to make them as much information as you can provide on the science as possible, but that historical information, particularly with the example.

<unk> III <unk> nine versus 594 number changes Bryan. So you wouldn't necessarily think too to look for that if you don't have the history. So I think I like that idea as well as the idea. We just heard from someone in the audience about actually having the link there.

Just one last step, but the one I was going to suggest in addition to that is.

[Analyst 1]: The one I was going to suggest in addition to that is particularly when you're looking at a partial recognition, right? Any information you can provide about why essentially what is recognized and what is not recognized, and specifically if you don't want something, what you do want instead. Now, you're gonna, I know you're gonna tell me that it cannot be, you know, that there are issues with it having it be guidance. Again, I do think that that is something that we would really find helpful.

Particularly when Youre looking at a partial recognition right any information you can provide about why essentially what is recognized and what is not recognized and specifically if you don't want something what you do want instead now youre going to I know youre going to tell me that it cannot be that their issues with it having it be guidance.

But.

And I do think that that is something that we would really find helpful.

Scott Colburn: Thank you, Jamie. That's, I'll say it's probably one of the constant improvement processes that we've been working on for a number of years. I would say I think we've come a long way, too. One of the things we really try to ensure is that if we are not recognizing a complete standard, if there's an issue with a particular area that we call it out clearly. We try to, you know, provide the rationale for that partial or for that section not being. Maybe it's in conflict with an existing regulation or guidance. If so, cite that and try to, you know, draw a line essentially right to where is the replacement for the part that's not being recognized, if that replacement is of critical.

Thank you Jamie.

I'll say, it's probably one of the Thompson improvement processes that we've been working on for a number of years and I would say I think we've come a long way too.

One of the things, we really try to insurers that if we are not recognizing the complete standard.

And if there is an issue with a particular area that we call. It out clearly, but we tried to provide the rationale for that partial for that section that.

Maybe it's just in conflict with an existing regulation or guidance on if so site that and tried to lens.

Your line essentially right to where is the replacement for the part that's not being recognized if that replacement is.

Scott Colburn: There are a few partials that we have specifically don't recognize because it's not underneath maybe our jurisdiction or it's not pertinent to what we're looking for. I think in the majority of cases that you're referring to, we do. One of our goals is to always try to tie that into something in the public domain that is known so we can say, "This is what we feel is necessary with the rationale to support that." If there are areas that you feel that are not clear, again, feel free to always try to contact us, and we can try to-

Of critical there are a few parcels that we have that we specifically don't recognize because it's not underneath maybe our jurisdiction or it's not pertinent to what we're looking for.

But I think in the majority of cases that you're referring to.

Do our one of our goals is to always try to tie that into some sort of something in the public domain that is known so we can say. This is this is what we feel is necessary what the rationale to support that.

Scott Colburn: If there are areas that you feel that are not clear, again, feel free to always try to contact us, and we can try to say, you know, that we're going on this. Our goal is to make sure that the recognition of standards, if anything, helps provide some clarity on how to use the standard. If we find that in how we've recognized it that it creates more questions than answers, then yeah, we need to continue addressing that so it becomes clear.

If there are areas that you feel that are not clear again feel free to always try to contact us and we can try to.

[Analyst 1]: Mm-hmm.

Scott Colburn: Say, you know, that we're going on this. Our goal is to make sure that the recognition of standards, if anything, helps provide some clarity on how to use the standard. If we find that in how we've recognized it that it creates more questions than answers, then yeah, we need to continue addressing that so it becomes clear.

But we're going on this our goal is to make sure that the recognition of standards. If anything helps provide some clarity on how to use the standard.

But if we find that in how we recognize that that creates more question.

Questions and answers and yeah, we need to continue addressing that so it becomes clear.

[Analyst 1]: Thank you, Scott.

Scott Colburn: Thank you. All right. No other hands. What would be our next question?

Thank you Scott Thank you.

On the other hands what would be our next question.

Terry Woods: Let's see. Here's one. Can you submit a DOC if there are differences between the test article and the proposed device? If so, should you include the rationale of why the test results are still relevant on the DOC itself or on the test report? This sounds like it may actually be a deviation, depending on, you know, whether or not the standard allows you to use a test article of the sort that you're talking about. That one we need a little bit more information. If you have deviated from a standard, then that's not something that's appropriate for a Declaration of Conformity. If you've done something that was a choice within the recognized standard, then you can include that in the Declaration of Conformity.

Hum.

Let's see here's one can you submit a dfc if there are differences between the test article and the proposed to buy it.

Should you include the rationale why the test results are still relevant on the GSE itself on the test report.

This sounds like it may actually be a deviation depending on weather.

Whether or not the standard allows eugene.

To to.

To use a test article of the sort that you are talking about so that one we need a little bit more.

More information so you have deviated from our standards and that's not something that's appropriate for a declaration of conformity, but if you've done something that was a choice within the recognized standard and you can include that in the declaration of conformity and as part of your Supper.

Terry Woods: As part of your, supplemental information, you'd need to provide a rationale as to why you made the choice that you did or why you chose the test article that you did.

Supplemental information you'd need to provide a rationale as to why you made the choice that should be at a point you chose the test article.

Yeah.

Scott Colburn: Okay. Make sure we're not answering.

Yeah.

As triangle.

<unk>.

Sure that answering.

Okay.

Terry Woods: I guess there was also a question about education. We in the past have done some education and I guess information that or a request that education with examples and, you know, specific, you know, specific examples should be included. That's something that we will definitely take into consideration. Again, one thing that we've all learned is how much easier Zoom or how we can be effective with Zoom meetings. We will consider, you know, what kind of additional information or education that we've done in the past that we could also share again in the future through Zoom meetings like this.

I guess there was also a question about.

Education.

In the past have done some education and I guess the information that.

A request that education with examples in in.

Specific.

And specific examples should be included.

That's something that we will definitely take into consideration and again one thing that we've all learned is how how much easier zoom.

How we can be effective with zoom meetings, and so we will consider.

What kind of additional information or education that we've done in the past that we can also share again in the future threes in meetings like this.

Scott Colburn: Okay. One thing we wanna make sure, you know, a lot of people, you know, going back to the communication tools and stuff, a few of the things that we do, as someone said, you know, a big part of this is making sure the regulatory affairs departments of manufacturers are in line and in tune with understanding the appropriate use. It doesn't just happen from bench to bedside. We have to go through many hurdles of regulatory affairs and regulators to get to that approach.

So one thing we want to make sure a lot of people going back to the communication tools and stuff I'm a few of the things that we do have someone said you know a big part of this is making sure. The regulatory first departments manufacturers are in line and in tune with understanding the appropriate.

Use it doesn't just happen from bench to bedside, we have to go through many hurdles of regulatory affairs and regulators to get to that.

Scott Colburn: Yes, we do work a lot with different regulatory organizations and industry associations, and are always open to try to help improve knowledge on that, as we also try to do within our own organization to ensure, you know, new reviewers and existing reviewers receive information and work across the OHTs, OPEQ, and OCEL and other organizations across the center. Knowledge is key, and education is very important. I would say also, you know, if you are a part of a RAPS chapter, we have historically worked with organizations like RAPS and do either the big RAPS meetings or sometimes come out for chapter meetings to talk about topics and on this area. That is one way we try to reach out to the regulatory community.

Scott Colburn: Yes, we do work a lot with different regulatory organizations and industry associations, and are always open to try to help improve knowledge on that, as we also try to do within our own organization to ensure, you know, new reviewers and existing reviewers receive information and across the OHTs, OPEQ, and OCEL and other organizations across the center. Knowledge is key, and education is very important. I would say also, you know, if you are a part of a RAPS chapter, we have historically worked with organizations like RAPS and do either the big RAPS meetings or sometimes come out for chapter meetings to talk about topics and on this area. That is one way we try to reach out to the regulatory community.

Approach. So yes, we do work a lot with different.

Regulatory organizations, our industry associations and are always open to try to help improve knowledge on that as we also try to do within our own organization to ensure new reviewers and existing reviewers receive information and work across the <unk> and <unk> with those sell and other organizations across the center knowledge is key.

And education is very important I would say also if you are a part of our reps chapter we have historically worked with organizations like rats and do either.

Big reps mediums or sometimes come up for chapter meetings to talk about topics and on this area. So that is one way we try to reach out to the regulatory community and then also through other tools, whether it be updates to guidance and others.

Scott Colburn: Also through other tools, whether it be updates to guidance and others. The parts too that we wanna look at, in terms of, you know, what can we do is, you know, we'd like to, again, keep hearing from you on areas of education that you think would be important for different areas within your organization as a body. We know we work closely with some of, again, trade associations and standard developing groups, which helps hit different stakeholders within an organization, just like we do it internally with our own. Let's see what can we do with this. We did that one already.

The parts to that we want to look at.

In terms of.

What can we do is we'd like to again keep hearing from you on areas of education that you think would be it would be important for different areas within your organization as a body and we know we were closer to summer again trade associations standard developing groups, which helps hit different stakeholders within an organization just like we do it internally with our own.

Hum.

Yes.

Terry Woods: That one we already answered.

Okay.

Scott Colburn: Yeah, we did that. One thing I did want to say too, we do try to update when we make a change to our recognition to CDRH New. So if you're subscribed to get the CDRH New, when we make updates to our recognition, it does go through portals like that. So while we don't have a subscription to the current recognition database, we do always go through channels like that, and in any other means as possible as well. We would be interested in seeing any other comments about the three questions to see what else could we do to help advance the use, make it easier for you to use standards, and what are the types of tools and resources. Let's see. Backing on this.

Yes.

One thing I did want to say too we do try to.

Date, when we make a change to our recognition to CD RH, new so if you subscribe to get the CD rates, new when we make updates to our recognition that does go through portals like that so while we don't have a subscription to the current recognition database, we do always go through channels like that.

And then any other means as possible as well.

Again would be interested in seeing any other comments about the three questions to see what else can we do to help advance the use.

Make it easier for you to use standards and what are the types of tools and resources.

Thanks Andreas.

Yes.

Scott Colburn: Did we hit the one about DOC for recognized that's partially? What do we do about clause or sections not recognized?

So if we hit the winter boat TLC for recognize Thats, partially what will be the closet section is not right now.

Terry Woods: No.

Scott Colburn: We'll keep hitting questions that are being asked, but again, please, continue to submit comments. Well, let me go to Tony here first. Tony, you have your hand up again. Why don't we unmute Tony?

So we'll keep getting questions that are being asked but again please.

Many of the comments well, let me go to Tony here first Tony of your hand up again, why don't we have no Tony.

[Analyst 2]: Yeah. It's a little bit, again, repetitious from my previous question and comment, but I was thinking, I don't think it's anything to sort of be ashamed of, if that's the right word. Everything has to start from somewhere, and everything has to try to best move forward from where it is. I think sometimes an assessment of where things stand helps us understand what work we need to do to move forward.

Yes.

It's a little bit again repetitious from my previous question and comment, but I was thinking.

I don't think it's anything to sort of.

Be ashamed of if thats. The right word is everything has to start from somewhere and everything has to try to best move forward from where it is.

But I think sometimes an assessment of where things stand.

Helps us understand what work we need to do to move forward. So again I just want to offer the comment that I.

Scott Colburn: Mm-hmm.

[Analyst 2]: Again, I just want to offer the comment that I think that we have a lot of work to do in this regard. The reason I think that is I think it's actually the vast minority of testing right now that needs to be submitted in support of a medical device that it's possible to do what you're saying. I just think the standards just are not there for the vast majority of testing that have methods, acceptance criteria, and circumstances that can support the use of a Declaration of Conformity. Maybe that's just it. It doesn't answer how to get there, but it answers where we're maybe starting from, at least in my experience.

I think.

We have a lot of work to do in this regard and the reason I think that is I think it's actually the vast minority of testing right now.

Needs to be submitted in support of the medical device.

That it's possible to do what you are saying I just think I think with standards just are not there for the vast majority of testing that have methods and acceptance criteria and circumstances that can support the use of the declaration of conformity and maybe that's just it doesn't answer how to get there but it.

Answers, where we're maybe starting from that at least in my experience.

Scott Colburn: Mm-hmm.

Terry Woods: Uh-

Scott Colburn: Go ahead. Nope.

Got it Okay go ahead.

Terry Woods: This is Tony. I mean, I think you're right. There's a lot of room for improvement in SDOs. That's some of what our 400 liaison recs that we have are going out to SDOs working on individual documents to make them again more regulatory ready. So you're absolutely right. You know, while you know we are where we are, this is not a process that's gonna be finished in you know a year or two years. It's something that we need to all collaborate together with to continue working forward to again to get test methods more well-defined, to get summary test reports or the test reports within the test methods better defined, to come up with acceptance criteria when we can.

Tony I mean, I think you're right. There is theres a lot of room for improvement in Fbl's. That's some of what our 400 liaison reps that we have are going out for Ses working on individual documents too to make them.

Again, more regulatory ready so you're absolutely right.

While we are where we are.

This is not a process that's going to be finished in a year or two years, it's something that we need to all collaborate together with to continue working forward to again to get Hazmat has more well defined to get summary test reports of a test reports within the test methods better define.

<unk> to come up with the acceptance criteria and Mccann.

Terry Woods: Again, you know, it's baby steps and we had to start with the state of things where they are. But I think we're now at the point where we can work with this evolution of standards to get them to be more useful, both for manufacturers and for FDA. Because again, you know, it's everything we can do to give people assurance that the test methods are appropriate and the results are what we need, is gonna help get devices to patients more quickly. That's, you know, at the end of the day, that's what we're all trying to do.

Again, it's baby steps and we had to start with the state of things, where they are but I think we're again now we're at the point, where we can work with this evolution of standards to get them to be more useful both for manufacturers and per FDA because again, it's beth.

Everything we can do to give people assurance that the test methods are appropriate and the results are what we need is going to help get devices to patients quickly and that's at the end of the day, that's what we're all trying to do and.

Terry Woods: Again, I think you know the voluntary consensus standards process is an amazing forum for us to work in because that is a place where FDA can work collaboratively with industry, you know that's not a device-specific application at the time, and we can collaborate and come up with the best way to assess devices to show if you know they do what they're supposed to do.

And again I think that the.

Voluntary consensus standards process is.

Amazing Forum for us to work in because that is a place where FDA can work collaboratively with industry. That's not a device specific application at a time and we can collaborate and come up with the best way to assess devices to show it.

They do what they're supposed to do.

Scott Colburn: Yeah. I would like to add on to that, too. I think, Tony, I think you're spot on. I think many of our review staff would agree with you, too, that most standards may require that, you know, a pretty large chunk of information needs to support the attestation of conformance or the understanding that you're using that, so what is the value of a Declaration of Conformity gets asked secondly. It goes back to the communication that it does provide. I think, you know, we've seen a struggle with, you know, how standards have come from simple methodologies with, you know, with endpoints built in, and they're not tied into risk management and all these other tools.

Yeah, I would like to add on to that too I think Tony I think youre spot on I think many of our review staff would agree with your two most standards may require that.

Pretty large chunk of information needs to support that.

Attestation of conformance or the understanding that youre using that.

So what is the value of the decoration performing gets asked secondly, but it goes back to that the communication that it does provide.

And I think we've seen it a struggle with how standards have come from simple methodologies with.

With endpoints built in and Theyre not tied into risk management and all these other tools.

Scott Colburn: You know, standards have become a lot harder to pin down in that way because we're trying to have them keep up with technologies that are always rapidly evolving. I think one of the ways, and this is to speak to all the stakeholders here, is, you know, we need to connect more with the other stakeholders that use standards, not just regulators, and not just users of products, and not just the manufacturers, but also the testing organizations and those who are looking at how they develop the competencies to demonstrate that they're competent in doing testing and what could go into a standard to help communicate consistency across the board testing procedures, qualifications that maybe need to be considered.

We all standards have become a lot harder to pin down in that way because we're trying to have them keep up with technologies that are always rapidly evolving.

I think one of the ways and this is a speak to all the stakeholders here is we need to connect more with the other stakeholders that your standards not just regulators and not just users of products and not just the manufacturers, but also the testing organizations and those who are looking at how they develop the competencies to demonstrate that the competition doing testing.

And what could go into a standard to help communicate consistent across the board testing.

Procedures.

Vacations that maybe need to be considered these are some of the things that we identified when we built when we worked with <unk>, a little bit as well as in our assessment of looking at the vast types of standards testing approaches that are conducted across our recognized standards and when we started building. The aska program, we really started covering <unk>.

Scott Colburn: These are some of the things that we identified when we worked with IMDRF a little bit, as well as in our assessment of looking at the vast types of standards testing approaches that are conducted across our recognized standards. When we started building the ASCA program, we really started uncovering areas of understanding the approaches, the rigor in conformity assessment done from a inspection body or, you know, accreditation bodies and what labs have to go through, the responsibilities that manufacturers have under the quality system to work with a testing organization and ensure that their quality system meets the needs because they're doing testing for your product.

As of of understanding the approaches the rigor and conformity assessment.

Done from a L inspection body or accreditation bodies, and what labs us to go through the responsibilities that manufacturers have under their quality system to work with a testing organization and ensure that their quality system, Amit needs because they're doing testing for your product and theres a lot of aspects to that but I think the standard could benefit from and how it construct.

Scott Colburn: There's a lot of aspects to that that I think a standard could benefit from in how it constructs itself to communicate what's necessary to support the types of testing that are being conducted in this. That's a big, you know, ask, but I think that's something that we're gonna see in this next generation of standards development, where the previous generation incorporated risk management and all these ways to try to maintain, you know, what is safe, how did you mitigate risks, how are you managing appropriate changes in a standard to keep up with technology.

<unk> staff to communicate what's necessary to support the types of testing that are being conducted in this so there's a that's a big big ask but I think that's something that we're going to see in this next generation of standards development.

Where the previous generation incorporated risk management in all these ways to try to maintain what is safe save how to mitigate risks how are you managing appropriate changes in our standard to keep up with technology, but I think if we incorporate more of the stakeholders and the performance assessment World with standards development.

Scott Colburn: I think if we incorporate more of the stakeholders in the conformity assessment world with standards development, we can strengthen our standards in ways that will help reduce the burden on regulators and the regulatory affairs professionals that are trying to use standards to communicate. That was a lot of words.

Strengthen our standards and ways that will help reduce the burden on regulators and the regulatory affairs professionals that are trying to use standards to communicate.

That was a lot of words.

Terry Woods: Um.

[Analyst 2]: Thank you.

Scott Colburn: Yes, thank you.

Thank you yes. Thank you.

Yeah.

Terry Woods: Okay. Someone else is making a comment that the Appropriate Use guidance of how to use consensus standards is not particularly clear. I guess I wouldn't entirely disagree with you. Again, you know, we do the best job we can at the time and so when we came out with that guidance in, I think it was 2018, you know, that was our first effort. We appreciate the feedback. Again, any more specifics you can give us, that will help us rethink and try to make things more clear. I guess we've heard that we would like to see examples.

Okay someone else is making a comment that that.

The appropriate east guidance.

How do you use consensus standard does not particularly clear.

And I guess I wouldn't.

When they entirely disagree with you.

Again, we do the best job, we can at the at the time and so when we came out with that.

<unk> in I think it was 2018.

Yeah that was our first effort.

We appreciate the feedback and again any more specifics you can give us.

That will help us rethink and try to make things more clear I guess, we've heard that we would like to see examples.

Terry Woods: We would like, again, you would like more clarity and so, anything specific you can tell us about what would make it more clear would help us to do, you know, to do a better job in reconsidering and reformulating what that guidance says and get the information to you so that it does make sense and it makes it easier for you to submit Declarations of Conformity.

We would like again, you would like more clarity in and so.

Anything specific you can tell us about what would make it more clear would help us to do.

To do a better job in reconsidering and Reformulating.

What that guidance says in getting information to you submitted it does makes sense and it makes it easier for you submit declarations.

Okay.

Scott Colburn: I think the key too is, you know, we also wanna know, you know, so you can flip that question around and say, "Well, what's the value of a Declaration of Conformity if I'm giving everything all the time? That seems to be what's working for me." I'll flip that question right back around too and say, "What's the value of recognition?" Is recognizing standards of high value to you in what we do or would another approach be, you know, something of higher value? Recognizing that a Declaration of Conformity again goes back to what I'm saying, it's a communication tool, it indicates that we're aware of a standard and, you know, we're with you on the journey to try to understand how you're using it appropriately for its regulatory use.

But I think the Q2 as you know we also wanted to know so.

You can flip the question around and say well, what's the value of a declaration from formally if im giving everything all the time that seems to be what's working for me.

I'll flip that questionary background to it and say, what's the value of recognition.

As recognizing standards of high value to you and what we do or whether another approach.

Something of higher value.

Recognizing that a declaration confirming again goes back to what I'm, saying, it's a communication tool and indicates that we're aware of a standard then we're with you on the journey to try to understand how youre using it appropriately for its regulatory use.

Scott Colburn: What do you need to support that document goes back to the construction of that standard. There are certain types of standards, certain design specification standards you could claim conformity to. To Tony's point, I think they are a little bit few and far between in some cases depending on the product that you have. In others, maybe not so much. The key thing is we're trying to find a way, ways to work with the standards development and conformity assessment cycles to have a clearer communication that goes further and deeper into what is it that you need to support.

Other after that what do you need to support that document goes back to the construction of that standard and there are certain types of standards certain design specification standards that may not have you could claim conformity too.

To Tony's point I think they are a little bit few and far between in some cases, depending on the product that you have and others, maybe not so much.

But the key thing is we're trying to find a way ways to work with the standards development and performance assessment cycles to have a clearer.

Communication of that goes further and deeper into what is it that you need to support maybe it's a complete test report, but maybe it's a complete test report has a format that can be utilized it helps us get consistent approaches and it helps us understand differences in the device technologies and approaches that are used that helps us lower burden on everyone.

Scott Colburn: Maybe it's a complete test report, but maybe if that complete test report has a format that can be utilized that helps us get consistent approaches, and it helps us understand differences in the device technologies and approaches that are used, that helps us lower burden on everyone involved as well as it helps you lower burden as well. Jamie has her hand back up. Why don't we go back to Jamie?

Involved as well as it helps you lower burden as well.

Jamie as her hand back up whenever we go back to Jamie.

Okay.

[Analyst 1]: Thank you. Sorry, not trying to be obnoxious, you know, we are passionate about standards. To Terry, to your point about specificity and what would make the guidance more helpful or more clear, right? This wasn't one of your original questions, but we do have a thought about this, which is in regard to transition periods, right? One of the things that has been sometimes challenging for our members is not knowing in advance how long those transition periods are going to be, and sometimes finding that they are quite short, sometimes less than a year.

Thank you Sarah.

Alright, not trying to be obnoxious just do we are passionate about standards.

So to the carry to your question to your point about <unk>.

The facility and what would make the guidance.

More helpful or more clear right. This wasn't one of your original questions but.

We do have a thought about this which is in regard to transition periods right.

One of the things that.

Has been sometimes challenging for our members is not knowing in advance how long those transition periods are going to be and sometimes finding that they are.

Quite quite short, sometimes less than a year and I think.

[Analyst 1]: I think, you know, if our recommendation continues to be that there should be, you know, in general, a presumption of a three-year transition, unless of course there's some, you know, pressing health justification for which you would provide, you know, an explanation. But another idea we had was, you know, potentially like a provision of a comment period during which those who are, you know, really well familiar with how a new standard is going to affect the particular manufacturer, given of course that FDA knows many things, but perhaps, you know, no one can know everything, that it might be helpful to have a comment period where we could opine on the specifics of the transition period for a particular standard.

Our recommendation continues to be that there should be in general a presumption of a three year transition unless of course, there is some pressing health justification for which you would provide an explanation.

But another idea we had was potentially like a provision of a comment period during which those who are really well familiar with how the new standard is going to affect that particular manufacturer given of course, the FDA knows many things, but perhaps no. One can note every everything that it's it might be helpful to <unk>.

Have a comment period, where we could opine on the specifics of the transition period for a particular, a particular standard.

Scott Colburn: Yeah. No, thank you. Transitions has been a topic for a number of years, and I know we've tried to take some approaches to be as, you know, judicious in how we go into the discussion on what is an appropriate transition period. I did touch on it a little early on what we try to do, whether it's a one-year or a three-year. A presumption of three years, I think. You know, I think what we would like to hear, maybe Jamie, I can put you back on the spot and say-

Yes. Thank you transitions has been a topic for a number of years and I know we've tried to take some approaches to he is.

Judicious in how we go into the discussion on what is an appropriate transition period.

Did touch upon it.

Little early on.

And what we've tried to do whether it's a one year or three year.

Resumption of three years I think.

I think what we would like to hear maybe Jamie I could put you back on the spot and so it gives you the answer.

[Analyst 1]: Yes, you can. Let's hear it.

Scott Colburn: Give me examples of why a long transition period would always be best from a presumption, in the recognition versus, say, one year. I don't know. If you could give us a few examples, so that way we could hear that.

Examples of why.

Long transition period would always be best from a presumption okay.

It isn't as recognition versus say one year I don't know if you could give us a few examples so that way we can hear that.

[Analyst 1]: Let's see here. I'm trying to remember some of the specific examples that they gave me, right? Because, of course, the members are much more close to this than I am. I think one of the ISO 10993-2 apparently had a very short period. I mean, I think the general idea, right, is that development cycles can be quite long, right? That you're developing a medical device, right? They can be quite long, and that it can be difficult essentially to incorporate a new standard, particularly one, right, there are particular ones, and it is, I think, sometimes very, very dependent on the particular facts of that particular device, where a standard will potentially impact design, testing, and acceptance criteria.

Let's see here I'm trying to remember some of the specific examples that they gave me right because of course the numbers are much more close to this and I am right, but I think.

One of the 10 99 three dash to.

Apparently had a very short period I mean, I think the general idea of it right is the development cycles are quite can be quite long right that youre developing youre developing a medical device.

So they can be quite long and then it can be difficult essentially to incorporate a new standard, particularly one for their particular ones and it is I think Barry sometimes very very.

Dependent on the particular facts of that particular device.

Where standard will potentially impact design and testing and acceptance criteria. So I think that's the reason the reason for the presumption I mean, you have seen some significant international bodies, you standard development bodies, the organizations use that rate as their baseline.

[Analyst 1]: I think that's the reason for the presumption. I mean, you have seen some significant international bodies use standards development organizations, right, as their baseline. I think the idea is essentially that. You know, there's the development cycle, and you need to know in advance, and it can be very difficult, particularly if you don't know it's coming. Now, again, hopefully everybody should be involved in developing the standard, but that it can be quite, you know, it can be challenging to do things in a short period of time. It's certainly something where I would be happy to go back to the experts and ask them to provide additional justification, but that's my understanding.

But I think the idea is essentially that.

So we have a fairly in others the development cycle and you need to know in advance and it can be very difficult.

Particularly if you don't know it's coming now again, hopefully everybody should be involved in developing the standard but.

That it can be quite area can be challenging to do things in a short period of time.

It's certainly something where I would be happy to go back to the experts and ask them to provide additional justification, but thats my understanding.

Scott Colburn: No, it's a real important topic, and it's one we're really trying to make sure too that we're being least burdensome in our approaches, but we're still trying to address any public health advances that are being brought about by the use of that newer standard. I think to your point, you know, how can we best, you know, make sure that there's an expectation or approach. We could, you know, dive a little bit deeper into an upcoming, you know, advancement and or guidance or other communication on this topic. Some of the things, too, I know that your experts have said, too, you know, in order to consider using newer standards, you know, you go through that whole risk management process.

It's a real important topics that's when we're really trying to make sure to it we're being least burdensome and our approaches that are still trying to address any public health advances that are being brought into by the use of that newer standards.

But I think to your point of how can we best make sure that there's an expectation or our approach and we could.

Dive a little bit deeper into an upcoming advanced in our guidance or the communication on this topic.

Some of the things to I know that your experts said to you in order to consider using newer standards. When you go through the whole risk management process.

Scott Colburn: You know, there's potential changes that may impact the risk management file and even the areas of the quality system, how things that are going into play. That takes time. In addition, especially let's use biocompatibility or EMC as an example, the organizations that test to those have to become accredited to the newer standard, which sometimes takes time as well.

There is potential changes that may impact of the risk management file that even the quality all areas of the Pos system <unk>.

How things that are going into play in.

That takes time in addition, especially what Skus biocompatibility or EMC as an example, the organizations that test to those have to become accredited to the newest standard which sometimes taking them.

[Analyst 1]: Mm-hmm.

Scott Colburn: That whole process does potentially take time. Realize too that when we're recognizing the standard, this is more speaking towards the submissions coming in versus the already cleared devices that are using the risk management process to determine when they should consider using or if they should consider using a newer standard. That part I know we get sometimes spliced in half on people worrying about a newer recognition that's timing out faster, but they were never intending to submit anyways. We have to make sure we understand how to appropriately use standards throughout the product life cycle of that is, of the medical device. I do think this is an area we would like to work more with in the standards development process as well.

So that whole process.

Potentially take time, but realize too that when we're recognizing the standard. This is more speaking towards the submissions coming in versus the clear already cleared devices that are using the risk management process to determine when they should consider using or if they should consider using our newest standard.

So that part I know, we get sometimes displaced and half on people worrying about newer recognition that's timing out faster, but they were never intending to submit anyway. So.

We have to make sure we understand how to appropriately use standards throughout the product lifecycle of that debt.

The medical device.

But I do think this is an area we would like to work more within the standards development process as well now I know a certain stl's like ISO on no longer allows us to put in our recommendations for authorities having jurisdiction on how they should use the standard.

Scott Colburn: Now, I know certain SDOs like ISO no longer allows us to put in recommendations for authorities having jurisdiction on how they should use the standard. IEC seems to let us. Other SDOs try to do it. If we're engaged in that process as a regulator, and this is, you know, something that we also try to teach, is try to learn what would be an appropriate transition by speaking to the members around the table, those who are closest to the standard, to give us an indication too of what would really take for you to need to transition.

IC seems to let us other STL is try to do it but if we're engaged in that process as a regulator and this is something we also try to teachers tried to learn what would be an appropriate transition by speaking to the members around the table those were closest to the standard to give us an indication to what would really take for you to need to <unk>.

Scott Colburn: The only thing that usually, you know, would knock that type of process off is if we really feel that the use of the older standard would potentially create a risk to public health or in the, you know, quality or performance that we're looking at. That is usually not the case because then we're typically looking at withdrawing that standard even before the newer standard or turning it into a partial. I would say maybe, you know, it's real important for users to understand what were the changes from one edition to the other. If they're very minor changes, sometimes we'll do a shorter transition period, but maybe we're assuming something that we shouldn't as well. Those are things too that you can always contact us on for reconsideration.

Transmission.

The only thing that usually.

We're not that type of process office, if we really feel that the use of the older standard would potentially create a risk to public health or in the quality of performance that we're looking at that is usually not the case. Because then we're typically looking at withdrawing that standard even much more than your standard are turning it into a partial.

I would say.

It's really important for users to understand what were the changes from one addition to the other.

It's a very minor changes, sometimes we'll do a shorter transition period, but maybe we're assuming something that we shouldn't as well so.

Are things too that you can always contact assigned for reconsideration, we have had that down a few times and had to extend their transition.

Scott Colburn: We have had that done a few times and had to extend the transition, where it seemed appropriate. You know, always never be afraid to contact us.

It seemed appropriate so I'm always never be afraid to content.

[Analyst 1]: Yeah. I mean.

Terry Woods: I follow up on that.

Yes.

[Analyst 1]: Oh.

Matt.

Terry Woods: Sorry, Terry. Were you saying something? Well, yeah, I was gonna say one other thing that you and the other SDOs might go back and other groups to ask your members about, in a case of like PMA devices, where a lot of the standards testing is bench testing that's done before there's a clinical trial. You've got that long period of time when the clinical trial is going on. Potentially you could have had new editions of standards that were published and recognized after you've done your bench testing before the clinical trial is finished.

Alright.

Well, Yeah, I was going to say one other thing that you and the other SCS micro backend.

<unk> and other grew fast as crew members about.

In the case of like PMA devices, where.

A lot of the standards testing is in bench testing thats done before there's a clinical trial and so you've got that long period of time on the clinical trial is going on so potentially could've had new editions of standards that were.

They were published and recognized after you've done your bench testing. The clinical trial is finished and so I get some feedback from people who have lived through that experience to us would be helpful too.

[Analyst 1]: Mm-hmm

Terry Woods: I guess some feedback from people who have lived through that experience to us would be helpful to again, just that experience is something that, you know, we can imagine, but if you guys don't tell us, then we don't really know how you do work with that, where you've done your bench testing and then, you know, 2 years later, you're ready to submit your PMA and there's new versions of these 5 standards that you used.

Again, yes.

That experience is something that we.

We can imagine that if you've got some tell US then you don't really know how how you do work with that where you've done your bench testing and then two years later, you're ready ready Snatcher, PMA and Theres new versions of these five standards that you used.

[Analyst 1]: Yeah, no, that's a very interesting point and certainly something to inquire about further. I did have one follow-up, if I may, Scott, to your point about, right, contact you and, you know, there have been instances where that transition period will change, and my understanding is that some of my members have done that with success and of course appreciate your collaboration on that. The only thing that has been mentioned about that is that, right, the manufacturer often will not know until the end of that transition, like almost the end of the transition period, right? Because it's so short to begin with, whether or not it's going to be extended. It's sort of a, well, we don't know if we're gonna get the extension, so we need to do the work and prepare anyway.

Yes, no. That's a very interesting question and certainly something to inquire about further I did have one follow up if I'm. If I may ask Scott to your point about rate contact you in and.

And there have been instances, where that transition period will change and my understanding is that some of my numbers have done that with success and of course appreciate your collaboration on that the only thing that has been mentioned about that is that you often manufacturing.

Manufacturing often will not know until the end of that transition like almost the end of the transition period right. Because it's so it's short to begin with whether or not it's going to be extended so it's sort of a well we don't know if we're going to get the extension. So we need to do the work and prepare anyway. So just to the extent that that there was.

[Analyst 1]: So-

[Analyst 1]: So, you know, just to the extent that. I realize it's hard 'cause, right, you need to think about it, you need to go through the process, all that kind of thing. It's just that that is potentially the challenge, that if a manufacturer doesn't know for sure that they're going to have that extension, they're gonna feel that they need to do the underlying work anyway.

Scott Colburn: Mm-hmm.

[Analyst 1]: You know, just to the extent that. I realize it's hard 'cause, right, you need to think about it, you need to go through the process, all that kind of thing. It's just that that is potentially the challenge, that if a manufacturer doesn't know for sure that they're going to have that extension, they're gonna feel that they need to do the underlying work anyway.

And I realize it's hard because where you need to think about it you need to go through the process all of that kind of thing. It shows that that is potentially the challenge is that if a manufacturer doesn't know for sure that theyre going to have that extension theyre going to do that they're going to feel that they need to do the underlying work anyway.

Scott Colburn: Yeah. There's those situations, I'm sure. I think this kinda goes back to, you know, how do we create the communication lines during the standards development process that would help the regulatory, you know, stakeholders at the table understand the nuances of standards implementation and, you know, some of the difficulties. You know, a lot of times we're looking at encouraging the newer version of a standard, of course, because we feel there might be less additional information to questions asked in a newer version, 'cause it may address some of the current issues that have been seen in the market or in postmarket surveillance that we have done. The newer version helps reduce that and reduces burden. Implementation is something that has to be weighed against that.

Yes.

Yeah there is.

Those situations I'm sure.

Just kind of goes back to how do we create that communication lines. During the standards development process that would help.

The regulatory stakeholders at the table understand the nuances of standards implementation and some of the difficulties.

Lot of times, we're looking at encouraging the newer version of our standard of course, because we feel there might be less additional information or questions asked in a newer version because it may address some of the current issues that have been seen in the market or.

And post market surveillance that we have done.

So the newer version helps reduce that reduces burden, but implementation is something has to be weighed against that.

Scott Colburn: That's why we always say, you know, if you're using an older version when a newer version exists, that is acceptable, but you may need to address some of the concepts that are introduced in that newer version if as part of your risk management file, and that could be addressed elsewhere in the submission of course. It's never the simplest answer when trying to talk about this, but I do think going back to early communication and understanding of the concepts of putting that standard to work and the nuances that go into that would help us in making sure we provide an appropriate transition into that. I appreciate that comment.

And that's why we always say if you're using an older version of an annual ratio success that that is acceptable, but you may need to address some of the concepts that are introduced in that newer version if as part of your risk management file and that can be addressed elsewhere. Its mission of course.

It's never the simplest answer when trying to talk about this but I do think going back to early communication and understanding of the concepts of putting that standard the work and the nuances that go into that would help us in making sure we provide an appropriate transition into that and I appreciate that comment.

[Analyst 1]: Thank you.

Scott Colburn: You know, I will say we did get a comment here that said that, you know, a 3-year cycle seems pretty long since the review of standards in ISO and ASTM take long, you know, aren't much longer than that. Like, you know, you can write a standard in 3 to 4 or 5 years. That's true too. You know, we tried figuring that part out. What's the best way? It's one of those, you know. You're in trouble if you recognize it right away, but you're in trouble if you let the old one go too fast. Yeah, there is a cycle that we're trying to use.

Yes.

And I will say, we did get a comment here on the set of a three year cycle seems pretty long.

The nice on SPM or take long aren't much longer than that.

You can write a standard of three to four or five years.

And that is true to and you know so.

We tried to figure that part out.

What's the best way its one of those.

You're in trouble, if you recognize it right away, but youre in trouble if you let the opens up too fast.

But there is a cycle that we're trying to use and I know you said youll see a lot of.

Scott Colburn: Like I said, you'll see a lot of two versions of a standard recognized with a timeout for the other one, but we wanna make sure we're doing that appropriately, and I think that's the point, Jamie, you're making, and we do agree with that, and we're trying to continually improve that.

Two versions of a standard recognized with a time out for the other one but we wanted to make sure we're doing that appropriately and I think thats the point, Jamie you're making and I do agree with that and we're trying to continually improve that.

[Analyst 1]: Yeah. Thank you for that.

Thank you for that.

Scott Colburn: All right. Oh, go ahead.

Alright.

Terry Woods: Well, I see one question that we should make it clear to everyone. It says: How can I assist FDA in revising guidance document? Every guidance document has what we call a docket, where you can make comments anytime for changes that you'd like to see or comments that you have on that guidance document. Again, the last few slides have some specific links to the guidance documents. If you search any guidance document online, there on that homepage that you find for that guidance document, there will be a link to the docket where you can put any comments that you like, and we review them periodically to help us in making revisions to a guidance document.

Okay, well I see one question that that we should make it clear to everyone says how can I assist FDA and revising guidance document.

Every guidance document has what we call a docket, where you can make comments anytime soon.

For changes that you'd like to see your comments that you have on that guidance document.

And the last few slides have some specific links to the guidance documents that if you search any guidance document online there on that.

On page that you find for that guidance document there will be a link to the docket. So you can put any comments that you like and we review them periodically to to help us in making revisions to the bank. So I encourage you to go to the docket and add anything at that we haven't covered here things that.

Terry Woods: I encourage you to go to the docket and add anything that we haven't covered here or things that occur to you later, and we will definitely review that in our work to revise all of the guidance documents.

Occur to you later, and we will definitely review that.

And our work to revise.

It's Joshua.

Scott Colburn: Yeah, absolutely. You know, if we decide that, based upon information collections that an update to the appropriate guidance would make sense, you know, when that draft gets published, that is another opportunity that we receive comments on, of course, as well. As Terry mentioned, there is an open docket on it. We also, you'll see later on an email address to CDRH Standards Staff where, you know, any comments or questions that you have, we're always happy to take those in and try to learn about how we can optimize this program for everyone's benefit.

Yeah.

Absolutely and if we decide that based upon information collections at <unk>.

An update to the appropriate guidance it makes sense when that draft. It's published that as another opportunity that we received comments on of course as well, but as Terry mentioned there is an open docket on it and and we also have Youll see later on in the mail adjusts. This year extended Stafford any comments or questions that you have were always happy to take those out and try to learn about how.

Or we can optimize this program for everyone's benefit.

Scott Colburn: You know, I always say this is the you know, we help support the medical device standards programs and, you know, for, FDA regulatory purposes, but the purposes that every stakeholder that's engaged with us as well. We wanna make sure that we're trying to do this and leading it with you. I think we're getting kinda close to the end. Maybe what we'll do is we'll go to the next slide and start closing out here. All right. We're showing. All right. Well, actually, Terry and everyone, boy, thank you all. This has been a really helpful and super discussion. Before we close, I wanna provide you with just the resources that we've been mentioning. On this slide, we have four of them. The, our webpage for the Standards and Conformity Assessment Program.

I would say this is the we help support the medical device standards programs and for.

For FDA regulatory purposes, but the purposes that every stakeholder that has engaged with us as well and we want to make sure that we're trying to do this and leading it with you.

So I think we're getting kind of close to the end maybe what we'll do is we'll go to the next slide.

And start closing out here.

Sean Alright, so actually carry and everyone, but thank you all it's been a really helpful and Super discussion.

Before we close I want to provide you with the resources that we've been mentioning on this slide we have four of them are webpage for the stance from reassessment program again S. Tap as our current us abbreviation of that and we have our webpage length. There are linked to FDA recognized consensus standards database and within that are the supplementary information.

Scott Colburn: Again, SCAP is our current abbreviation of that, and we have our webpage link there. A link to FDA Recognized Consensus Standards database, and within that are the Supplemental Information Sheets that we spent quite a bit of time focusing on. Look at them. Let us know what from your observation of the standards you are, you know, familiar with and utilize. You know, are there things that you think would be a little bit clearer on the approach based upon how that standard's construction is that we could use to improve based upon the discussions that we had today? Additionally, we have the links to the two FDA guidances, the Recognition and Withdrawal of Voluntary Consensus Standards and the Appropriate Use guidance.

So we spent quite a bit of time, focusing on and looked at them. Let us know what from your observation of the standard you are familiar with and utilized now are there things that you think would be a little bit clearer on the approach based upon how that standards. Construction is that we can use to improve based upon the discussions that we have today.

Additionally of the links to the two FDA guidance says the recognition withdrawal voluntary consensus standards and the appropriate use guidance <unk>.

Scott Colburn: We've also listed our email address that I mentioned before and hope that you'll use it to send any additional thoughts or questions that we were unable to get to today. Watch out in the future again for a public comment period that will open up when we draft if we do get into the drafting of the Appropriate Use Guidance. Next slide. ASCA came up a couple times and of course I would be remiss if we didn't mention it here and give you some resources. If you'd like to learn more about the Accreditation Scheme for Conformity Assessment, and we hope you will, there are several key resources, including the guidances that were published to implement the ASCA program. Next slide.

We've also listed our email address that I mentioned before and hope that you will use it to send any additional thoughts or questions that we did that.

Unable to get through today.

And watch out in the future again for a public comment period that will open up when we dropped it if we do get into the drafting of the appropriate guidance slide.

Yes.

<unk> came up a couple of times and of course I'd be remiss. If we didn't mentioned it here and give you some resources. So if you'd like to learn more about the presentation schema for conformity assessment and we hope you will there are several key resources, including the guidance says that we published to implement the Astra program.

Right.

Yes.

Scott Colburn: Finally, we encourage you to refer to CDRH Learn and Device Advice on the FDA website for an absolute wealth of information and support. A lot of the questions that were asked today can be addressed by diving into those. The educators at DICE are always eager to help support all of our stakeholders to work effectively and efficiently with the FDA. Next slide. We're getting towards the end. I think that concludes our workshop. I don't see any new hands or anything like that. If we did not get to your comments or if you have questions, please again, there is an email address that is listed here today at CDRHStandardsStaff@fda.hhs.gov.

And finally, we encourage you to refer to CRH learn and device suffice on the FDA website for an absolute wealth of information and support a lot of the questions that were asked today can be addressed by diving into those the educators at GIC are always eager to help support all of our stakeholders to work effectively and efficiently with the FDA.

On slide.

So towards the end so I think that concludes our workshop.

<unk> hands or anything like that.

If we did not get to your comments or if you have questions. Please again the email address that is listed here today at CD rates standard staff at FDA that HHS that G O V E.

Scott Colburn: You may as well submit a formal comment on this meeting's docket using the link on the slide or by searching Regulations.gov with the docket #FDA-2022-N-2781. Thank you again for joining us today and helping us out, putting standards to work. Have a wonderful holiday season, and we look forward to working with you in the future. Thank you. Thank you, Terri.

<unk> will submit a formal comment on this meeting started using the link on the slide are by searching regulation stocked up with the Doctor.

Yes, Jake FDA Dash, two zero to two deaths and that's $2 71.

Thank you again for joining us today and are helping us out property standards to work have a wonderful holiday season, and we look forward to working with you in the future.

Thank you. Thank you Terence Thank you all for coming.

Terry Woods: Thank you all for coming.

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