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Moderator: Irene Aihie

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FDA Webinar: Recognition and Withdrawal of 

Voluntary Consensus Standards - Final Guidance

Moderator: Irene Aihie

October 15, 2020

1:00 pm ET

Coordinator: Welcome and thank you for standing by. At this time all participants are in 

listen-only mode until the question-and-answer session of today’s conference. 

At that time you may press Star 1 on your phone to ask a question. I’d like to 

inform all parties that today’s conference is being recorded. If you have any 

objections you may disconnect at this time. I would now like to turn the 

conference to Irene Aihie. Thank you. You may begin.

Irene Aihie: Hello and welcome to today’s FDA Webinar. I am Irene Aihie of CDRH’s

Office of Communication and Education. On September 15, 2020, the FDA 

issued the final guidance Recognition and Withdrawal of Voluntary 

Consensus Standards. This final guidance explains the updated procedures the 

FDA intends to follow when the FDA receives requests for recognitions of 

consensus standards and withdrawals recognition of a consensus standard.

Today Donna Walsh and Jianchao Zeng, both Senior Standards Advisors in 

the Standards and Conformity Assessment Program within the Office of 

Strategic Partnership and Technology Innovation here in CDRH, will present 

an overview of the final guidance documents. They are both joined by center 
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subject matter experts to assist with the Q&A. Following the presentation, we 

will open the line for your questions related to the information provided 

during the presentation. Now I give you Donna.

Donna Walsh: Thank you Irene. Good afternoon everyone. My name is Donna Walsh and 

I’m a Senior Standards Advisor in the CDRH Standards and Conformity 

Assessment Program. Today my colleague Jianchao Zeng and I will be 

sharing with you information regarding the recently issued final guidance 

Recognition and Withdrawal of Voluntary Consensus Standards.

Next slide please. Our agenda today begins with an overview of the role that 

is played by the Standards and Conformity Assessment Program or S-CAP

with respect to FDA recognized consensus standards. We will then take a 

brief look at the types of comments that came in on the draft guidance from 

our stakeholders. 

We’ll review the main facets of the final version of the guidance which 

incorporates that stakeholder feedback. Then we’ll have a question and 

answer period. And then we’ll wrap things up with some concluding remarks 

before the end of the Webinar.

Next slide please. So let’s get started with our overview. S-CAP supports 

CDRH’s mission by driving the development, the recognition and the 

appropriate use of regulatory ready standards for medical devices throughout 

their life cycle. FDA encourages the voluntary use of recognized consensus 

standards in premarket submissions. Doing so offers several advantages such 

as increased predictability, a more streamlined premarket review and 

increased clarity of regulatory expectations, all of which can help facilitate 

market entry for safe and effective medical products.
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In addition, declarations of conformity may be used with recognized standards 

reducing the amount of supporting data and information that needs to be 

submitted to FDA in a pre-market application. So the use of voluntary 

consensus standards is a key element of regulatory science. When 

manufacturers cite FDA recognized consensus standards the review process 

can be more efficient.

And when declarations of conformity are made to recognized standards less 

documentation is typically needed. And at the same time, the utilization of 

consensus standards, which are written under conditions of transparency and 

inclusivity while effectively being crowd sourced among experts around the 

world, this enables medical device quality to be enhanced which benefits both 

clinicians and patients.

So let’s review what is meant by recognition. Recognition is FDA’s formal 

identification of a standard, reflecting a determination that it is appropriate for 

manufacturers of products to declare conformance to that standard, in order to 

meet relevant requirements including premarket submission requirements.

Next slide please. In order to promote the use of consensus standards, S-CAP

prioritizes the following recognizing standards through our formal Standards 

Recognition Program which we will discuss in greater detail in a few 

moments, encouraging the appropriate use of recognized standards in device 

premarket submissions, and actively participating in the development of 

national and international voluntary consensus standards. So how do these 

priorities translate into reality? Well here are some numbers to describe the 

depth of our commitment to standards.

We have 17 internal advisory Specialty Task Groups or STGs in 23 specific 

device and scientific areas. At last count there were about 400 CDRH staff 
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members who participate in around 600 national and international standards 

committees across 29 standards developing organizations.

There are currently roughly 1400 recognized standards in our database and 

more than 90% of those are complete recognitions meaning that a standard is 

recognized in its entirety. Over the past few years, we’ve typically had a 5% 

to 10% increase in requests for participation in new standards development 

activities each year. And based on a past survey that was done there are an 

average of seven standards cited in each 510(k) submission with a wide range

as you can see here on the slide.

Next slide please. So now that we’ve provided an overview of what S-CAP

does we’re going to shift gears to talk about our newly published guidance 

entitled Recognition and Withdrawal of Voluntary Consensus Standards. The 

final guidance formalizes several aspects of our Standards Recognition 

Program and provides clarity on other aspects. It was written with significant 

feedback from our industry stakeholders on the draft version which we’ll 

review next.

Next slide please. When looking at the types of comments that came in on the 

draft version of the guidance the commenters told us that the recognition 

process should reflect our Center’s least burdensome principles and that all 

aspects of the process should be clear and transparent. The comments also 

requested additional clarity on the use of transition periods including the 

rationale for recognition and other updates in the supplemental information 

sheet as well as a distinction between when a standard may be used in a 

submission versus when it is formally recognized.

And as Jianchao will explain once a standard appears in the Recognized Consensus Standards 

Database it may be cited in a premarket submission even if formal recognition 
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-- by publication in the Federal Register -- is still pending. Now please note 

that your comments on the guidance are still welcome. Final guidances remain 

open for commenting as long as they are in effect.

Next slide please. And now I will turn the presentation over to Jianchao to 

review some key elements of the final guidance in greater detail.

Jianchao Zeng: Thank you Donna. Next slide please. The next few slides summarize some of 

the main points of the guidance including specific information related to 

stakeholder requests for standards recognition including who may submit a 

request for recognition and what should be included in the request, the FDA’s

response procedures for such a request and how we intend to respond in 

writing with our decision within 60 calendar days. It discusses how the extent 

of recognition is determined to be complete, partial or non-recognition. The 

FDA will make public the rationale of our decision to either recognize or not 

to recognize a particular standard.

Next slide please. The guidance offers practical advice on the processes we 

follow and expectations for requests as well as key elements of the recognition 

program. It specifically addresses the value and the utility of consensus 

standards in product submissions, the elements of a request for recognition, 

updates to the supplemental information sheet including the extent of 

recognition and the rationale for that decision, updating the Recognized 

Consensus Standards Database with standards we intend to recognize, official 

recognition which occurs upon application of a Federal Register notice, and 

our procedures for withdrawing recognition of a standard including a possible 

transition period.

For example, when a newer version is published and FDA decides to 

recognize it the recognition of the older version of the standard will be 
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withdrawn. However, we may provide a transition period to the older version 

during which a declaration of conformity may still be accepted. Next slide 

please. 

Let’s talk about the practical aspects of the recognition process first. In order 

to request that a standard be recognized by FDA -- and anyone can submit 

such a request -- the elements listed below on this slide should be included.

Your name and address, the title of the requested standard, the standard’s 

reference number and date, a proposed list of product types for which a

declaration of conformity should routinely apply, the basis for recognition 

which may be scientific, technical or regulatory, and a brief identification of 

the testing, performance or other characteristics that a declaration of 

conformity would address.

Next slide please. Once a request or recognition has been received it triggers 

the following steps. An acknowledgment letter is sent to the requester. The 

standards program S-CAP organizes a formal review of the standard with the 

appropriate Specialty Task Group, STG. The review team makes a 

recommendation to the S-CAP regarding the standard recognition either 

recognition (which may be complete or partial) or non-recognition, along with 

a rationale for the recommendation which could be grounded in a scientific, 

technical or regulatory basis.

Next slide please. As I mentioned earlier the guidance formalizes some 

aspects of the recognition program. Recognition decisions should be made 

within 60 calendar days. The decision including the rationale will be sent to 

the requester. Pending recognition, FDA’s determination will appear in the 

Recognized Consensus Standards Database.
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Official recognition occurs upon publication in the Federal Register notice. 

Non-recognitions will be listed in the Non-Recognized Standards Database. 

Once again, I want to emphasize an important point. Official recognition 

occurs when the recognition list is published and a notice appears in the 

Federal Register. However, a standard may be included in a declaration of 

conformity as soon as it appears in the Recognized Consensus Standards 

Database as that indicates our intent to formally recognize it and therefore 

recognition is pending. 

You do not need to wait for the Federal Register publication. You may cite a 

standard in a declaration of conformity as soon as it is included in our

database.

Next slide please. Let’s go back to something we briefly mentioned earlier,

the Supplemental Information Sheet or SIS. Each recognized standard has its 

own SIS sheet in the Recognized Consensus Standards Database. It includes 

the following elements: A recognition number, the date the SIS was entered 

into the database, title of the standard including the SDO and the designation 

number, the US identical adoption if applicable, scope or abstract of the 

standard, extent of recognition whether it is a complete or partial recognition.

For example, currently we are recognizing both the IEC 60601-1-11 (a 

standard on medical electrical equipment and the medical electrical systems 

used in the home healthcare environment) and the US modified adoption 

ANSI/AAMI HA60601-1-11.

While the ANSI/AAMI version HA60601-1-11 is a complete recognition, the 

IEC version 60601-1-11 is a partial recognition due to differences in 

definition of home healthcare environment between this standard and FDA’s 

guidance. The SIS sheet also includes the rationale for recognition, transition 
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period if any, Specialty Task Group (STG) as well as additional items such as 

public law, CFR citations and product codes (if any), relevant FDA guidance 

or supportive publications, and FDA technical contact information.

Next slide please. Periodically we need to withdraw recognition of a standard

but we do not do it lightly. Typically it happens when a newer version of a 

standard is published and FDA decides to recognize it after a review. On rare 

occasions we maydetermine that a standard no longer meets our expectations 

or is no longer appropriate for meeting a requirement, and therefore we need 

to withdraw its recognition.

For example, a CLSI standard (point-of-care blood glucose testing in acute 

and chronic care facilities) was initially recognized on list 36 in July 2014. 

But subsequently it was withdrawn on list 37 in October 2014 because it was 

in conflict with an existing policy. If you have not already, please take a look 

at the Appropriate Use guidance for more information about withdrawing a 

recognition.

Next slide please. On the previous slide we talked about when it is necessary 

to withdraw recognition of a standard, for example, when a standard has been 

revised with a newer version. In these cases, FDA may implement a transition 

period. In determining the length of the transition period we consider the 

following factors.

The public health impact of delaying the use of the newer version, and 

potential difficulties the manufacturers may face in implementing new 

changes to a standard. The transition period allows additional time for the 

submitter to complete product development and testing already underway 

using the older version. It also allows them time to validate any new test 

methods in the newer version before using them for a submission.
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For example, a one-year transition is typically provided for a product specific 

vertical standard, while a longer transition time (say two to three years) could

be provided to a horizontal standard, a standard that impacts multiple product 

types such as biocompatibility, sterility, software, EMC, usability, alarms, et

cetera. The length of the transition period is spelled out in the SIS sheet before 

the Rationale for Recognition section. This concludes our slide presentation,

and we thank you for your attention. I will now turn it over to Irene.

Irene Aihie: Thank you Jianchao. This is Irene Aihie. Operator, we’ll now take questions 

from our participants.

Coordinator: Thank you. We will now begin the question and answer session. If you’d like 

to ask a question please press Star 1, unmute your phone and record your 

name clearly. Your name is required to introduce your question. If you need to 

withdraw your question press Star 2. Again to ask a question please press Star 

1. It’ll take a few moments for the questions to come through. Please stand by.

Donna Walsh: While we’re waiting for...

Irene Aihie: Go ahead.

Donna Walsh: While waiting for the question and answers to begin one common question 

that we are asked, sometimes relates to Form 3654. "What role does Form 

3654 play in my premarket submission?"

Well this form has actually been discontinued, and we found that it was never 

really used quite as we intended which was to collect data on standards use 

and submissions -- for example, with testing done by a third-party, were there 

any deviations? But instead people were incorrectly using Form 3654 more as 
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a declaration of conformity. And so because it created more confusion we no 

longer use it. But Form 3514, which is the CDRH Premarket Review 

Submission Cover Sheet, contains a section specifically for listing any 

standards used in your submission.

Irene Aihie: Thank you Donna. Operator, do we have any questions in queue?

Coordinator: Yes. Our first question is from Patricia Lehman. Go ahead your line is open.

Patricia Lehman: Hi hello. This is Patricia Lehman from Intuitive Surgical. Thank you so much 

for this Webinar -- very informative and for the opportunity to ask questions. I 

would like to know what the criteria is for the information put in the database 

when a standard changes revision and the agency publishes what the grace

period would be. What’s the criteria to actually have that information for 

some standards that get revised and not others?

Jianchao Zeng: So I will try to answer this question. So maybe Donna and Scott may add. So I 

think you are asking about the transition period. So as we mentioned that 

typically we provide a one year transition period to a product specific standard 

and two to three years or longer transition period for a horizontal standard that 

has multiple - that impacts multiple product types.

Patricia Lehman: So is this a horizontal...

Jianchao Zeng: Does that answer your question?

Patricia Lehman: So you wouldn’t provide that information? There wouldn’t be no transition 

period for horizontal standards? Is that what you’re saying?
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Jianchao Zeng: There will be the - yes in some cases we provide a transition period to 

horizontal standards which is a longer transition period than the product 

specific standard.

Patricia Lehman: Okay. I guess the - my question is if it’s not listed, if a standard is revised and 

there's no information on the database that there is a transition period the 

agency would expect that the manufacturer would conform to the very latest 

revision that’s recognized?

Jianchao Zeng: Correct right. If no.

Patricia Lehman: Okay.

Jianchao Zeng: ...transition period is provided that means that...

Patricia Lehman: Okay.

Jianchao Zeng: ...the older version is withdrawn and without a transition time.

Patricia Lehman: Okay understand. 

Scott Colburn: Hi. This is...

Patricia Lehman: Thank you there.

Scott Colburn: This is Scott Colburn. I’m the director of the program and I want to just kind 

of expand on this because there’s different situations that come into play when 

people ask about transitions. And first and foremost, please always realize that 

the use of a standard whether recognized or not is a voluntary aspect.
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These standards are not incorporated by reference into statute or regulation 

where it is required for them to be used. The recognition provides a

communication from the agency to a stakeholder on this is our current 

thinking on a tool that we think would be appropriate to use. 

That being said, you know, when we recognize a standard for the very first 

time we will recognize it without a transition period because there is no other 

standard that that new recognition superseded. Even if that standard might be 

the third or fourth edition of it, if it’s the first time the agency has recognized 

it, we will just recognize it because it’s voluntary. It isn’t required to be used 

in any sense.

The second part -- and this is the more common aspect -- is when a standard is 

recognized and then withdraws a previous edition that is already recognized as 

well. And that is when FDA will look at the standard and determine the 

impact of such standards transitional needs that was outlined in the slide that 

was discussed by Jianchao. You know, what is the impact of that standard 

towards the manufacturing changes, how does that impact possibly quality 

systems? What is the impact if that standard is traditionally done in a 

laboratory that needs to be accredited to such procedures, you know, because

there’s time that that takes?

Those are all elements that we take into consideration as well as we look at 

the public health advances that that standard may be addressing. If that 

standard is looking to try to help address a particular public health issue that 

we’re seeing we will want to try to drive or encourage manufacturers to utilize 

the more current version. But they are still allowed to use the older version. In

most cases a manufacturer may still be expected to address the differences in 

how public health, you know, situations are being addressed in the risk 

management file.
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So there’s different situations that can apply. So what we do is we try to 

identify that transition date and give it an appropriate thought process to make 

sure both that we’re looking at it from the public health responsibilities that 

we have as an agency as well as some of the challenges for implementation. 

And then we do try to take into account that $1 million question which is,

what are other agencies from other jurisdictions around the world also doing 

to try to help with the harmonization aspect of that internationally as one of 

our responsibilities?

Patricia Lehman: That clarifies. Thank you so much.

Coordinator: We show no further questions at this time. But again, as a reminder please 

press Star 1 on your phone and record your name if you have a question. One 

moment please.

Irene Aihie: While we wait for further questions...

Coordinator: Our next...

Irene Aihie: ...Donna - oh the questions are coming in.

Coordinator: Our next question is from Ron. Go ahead your line is open.

Ronald Reitan: Thank you. This is Ron Reitan with Boston Scientific. I’d like to revisit this 

topic of transition periods as well. You mentioned earlier that your default 

period for vertical standards might be like one year.

And there are a number of product standards vertical standards for rather 

complex products and I’m going to bring active implants into that mix --
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pacemakers, defibrillators, cochlear implants infusion pumps, 

neurostimulators.

A revision to those types of standard certainly involves a great deal of 

complex issues with likely retesting a lot of verification testing, validations. 

One year in my own humble opinion is a totally inadequate period of time for 

such things. And I’m wondering if you’re criteria which you haven’t 

elucidated yet actually takes into account those level of difficulties for a 

revision to those types of standards?

Jianchao Zeng: Thank you Ron.

((Crosstalk))

Scott Colburn: Yes. 

Jianchao Zeng: Thank you Ron.

Scott Colburn: Go ahead Jianchao.

Jianchao Zeng: Thank you Ron. Thank you for the question. Yes this is a good question. 

Actually, we had a lot of discussions on this. 

The one year the typical one-year transition is in general given to product 

specific standard. However we are open to discussions on a case by case basis 

for difficult products as you mentioned for - to discuss the possibility of 

extending that period. So it’s - but it’s not a kind of a general case it is a case 

by case that some - is a discussion on the case by case basis.
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So we did have this situations happen before and then we did extend the 

recognition for that purpose. So Scott you want to add more?

Scott Colburn: Yes and Ron this is a great question because vertical standards are impacted 

differently depending if they’re a part of a larger series. And I think you’re 

alluding to the IEC 60601/80601 family of standards where a lot of times 

impacts that come in on newer versions or amendments of those standards are 

based upon updates to more horizontal standards like the base or other 

collateral standards.

And in those cases, we see those more as horizontal impacts to a product 

standard which usually is impacting a series of product standards. And we 

tried to address that more from a horizontal aspect because we understand that 

there are larger things that come into play when looking at that. 

But there is a difference between that and say maybe I’ll just throw one out 

like a ASTM specific test method that’s addressing just one aspect of a 

material characteristic. That is something that may be something that isn’t 

needing as long as a transition period to address and that may see a shorter 

transition period.

So we do try to take into account what are the impacts to the changes being 

made to a product specific standard if they’re coming in from horizontal 

aspects that would impact certain things that would take a longer time for a 

manufacturer to adequately prepare for. And so I kind of hope that helps 

illustrate a little bit of what we’re trying to take into account when we look at 

appropriate transition periods.

That said we may not always get that right in our communication. And we do 

encourage you to contact us and we can have that discussion. We have also 
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been asking the standard developing organizations to have those types of 

discussions as well both at the national and international level so that way we 

can kind of hear and appreciate that during the development of the standard.

And that allows us to communicate that into the agency to make sure we're 

doing an appropriate mechanism of communicating when that transition 

period should be set.

And more importantly if someone chooses to use the older standard how they 

might need to make sure that any changes between the two that would impact 

the safety and effectiveness or some aspect that’s important to the overall 

regulatory review is addressed somewhere in the submission if appropriate.

Ronald Reitan: Thank you, Scott. If my line is still open here just a follow-up. I was referring 

primarily to the ISO 14708 series of standards which as you know consists of 

a general standard and several particulars for various device types. And a 

change to any one of those in my humble opinion would necessitate a longer 

transition period. 

And I’m happy to hear that, you know, you’re willing to take into account 

input from SDO, you know, ISO, IEC technical committees. Generally 

speaking we’ve seen, you know, FDA involvement in those committees in the 

past. And so I would hope that - by - through that participation they would see 

levels of difficulty that are coming into play and perhaps, you know, and not 

necessarily invoke a one-year default timeframe for a vertical standard like 

say ISO 14708-3 but rather set it appropriately upfront so we don’t have to 

necessarily come back and have that somewhat protracted discussion.

Scott Colburn: Yes, well thank you Ron. And I think, you know, that series and kind of 

looking at, you know, even that version, the most recent version kind of that 

was the timeframe when we really started trying to address transition periods 
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more readily. Historically if we look back at a decade ago or more we rarely 

did transition periods. We really just did a withdraw and replace with a few 

exceptions for some really very broad standards in the 60601 series or the, like 

a 14971 risk management standard or maybe a sterilization standard.

Prior to the appropriate use guidance publication, we really didn’t do that, but 

we saw the need to do so because we saw some of the struggles and 

challenges that were being placed. So with the appropriate use guidance in 

2018 we really started making strides in making that part of our policy for 

recognition and then we further tried communicating it into this guidance. 

So I think we’re - what we're really trying to impress is, you know, for our 

own liaisons from FDA to sit on the committees to try to look into that as an 

aspect of how we should recognize the standard but more importantly or just 

as important to make sure that our stakeholders like our industry experts and 

those who sit on the standards committees also try to discuss those as an 

aspect of, you know, how the standards should be published or if it’s an 

international standard and being adopted how that could be better 

communicated.

Ronald Reitan: Thank you for the feedback.

Scott Colburn: Yes.

Coordinator: Our next question is from (Steve Parrish). Go ahead. Your line is open.

(Steve Parrish): Yes, so good afternoon. I'm (Steve Parrish) with AbbVie. And I have to admit 

it’s a very specific question but there's a particular standard for infusion 

pumps 60601-2-24 that's been out since 2012. And unfortunately it doesn’t 
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fall on either list. It's not on the recognized list. It's not on the unrecognized 

list or the not recognized list. 

And just thought I’d - we - those of us in the infusion pump industry have 

been dying to know why it’s not on either list and I was wondering if anybody 

can provide an explanation as to why that is?

Scott Colburn: I’m happy to take the first swipe at that one if I may. There are, you know, 

some standards that we have not recognized that have not had a formal request 

for recognition. And a lot of times our non-recognition list which is new is -

has really been addressing those types of standards that come in for a formal 

recognition and a determination for to not recognize it because it’s not felt that 

it is suitable to support a declaration of conformity as to the appropriate 

decision.

The infusion pump standard that particular does have a bit of a history. And I 

think the agency's been trying to find better ways to communicate what's the 

appropriate information that would be supportive to make a regulatory 

determination through things like their guidance documents and so forth. 

That being said we’d, you know, welcome if you feel that that is a standard 

that based upon the tools that the agency is providing such as guidance 

documents or other means that the use of the standard would help support, you 

know, some of the priorities that is - that are important to the agency as well 

as industry if we could look at that and put, you know, get that in play.

The use of the standard is not prohibited because it is not recognized. It's just 

that the agency feels that the use of the standard towards a declaration of 

conformity wouldn't be appropriate. And so for standards that one, that are 
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being used to not support a declaration of conformity should go through the 

general use platform that's described in the appropriate use guidance.

And that would permit the review staff a little bit more of (robust) of data that 

they would be looking at in comparison to a structure declaration of 

conformity that might only have a small summary test report. So this is 

something that we would encourage you to engage with the agency on and 

we'd be happy to have further discussion on a particular standard such as 2-24.

(Steve Parrish): Okay thank you.

Coordinator: Our next question is from (Sheryl Laforte). Go ahead. Your line is open.

Sheryl LaFond: Good morning, it's Sheryl Lafond’s with Abbott Vascular. And I’m just 

curious do you have a metrics or some kind of way of identifying how much 

shorter your review times are or what the real visible measurable gains are for 

going that extra mile with the declarations of conformity to some of these 

standards?

Jianchao Zeng: Yes I can take a quick - a answer to this. The short answer is that it we don’t 

have specific number but we did try to measure in some way to see whether a 

standard - the recognition or a declaration of conformity how much it will be 

able to streamline the review process.

So it is - so in general the use of recognition standard would be able to help 

with the reviewers to understand the design and the testing process. And then 

of course yes, if it is a standard that is recognized, both the manufacture and 

the reviewers understand the test method and the pass/fail criteria. 
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So we understand that it will help the review process and has streamlined the 

process instead of we're asking additional questions multiple times back and 

forth. So the answer is that we don’t have a specific number but in general we 

feel that that’s the benefit of using the recognized standard.

Sheryl LaFond: Of course. Thank you very much.

Scott Colburn: I'd like to just add - yes I'd like to just add a little bit on because the use of a 

declaration of conformity which is the premise of what we have under Section 

514(c) in the act which is what developed the recognition program really was 

designed to try to help from the least burdensome principle to make it a little 

easier. 

But back in 1997 when that provision was written standards were designed a 

lot differently too. They were more objective based and a lot easier to navigate 

from a test report standpoint.

And today we know, you know, through other avenues such as risk 

management stuff, standards are very complex. So there is a challenge in 

finding out what is that right element of information that's necessary to 

support a declaration of conformity. 

We are - this is a topic that’s of the utmost interest for our - for the agency and 

really for all regulators as to what’s the right balance with the least amount of 

information that's necessary to support a declaration of conformity. And we're 

doing this in a couple different parts.

One is we're looking to try to do additional training such as like an industry 

basics that we're aiming for later this winter. We also have the accreditation 

scheme for conformity assessment pilot platform that’s looking at different 
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approaches too of how we can bring that information into a more succinct and 

focused amount. And this should hopefully be a least burdensome approach.

The goal is really trying to make sure that there’s clear communication 

between how it - a recognized standard is being utilized or tested to and how 

that is able to report a regulatory determination in a way that would reduce 

additional information questions and back and forth because that’s where, you 

know, any extra effort in developing a declaration loses itself if we're asking 

questions on that aspect.

So I encourage you to kind of keep an eye on further information and 

communication from the program on this topic and also welcome any 

questions you have by just sending an email to us and we'd be happy to take 

that on.

Sheryl LaFond: Thank you.

Coordinator: The next question is from Jeff Eggleston. Go ahead. Your line is open.

Jeff Eggleston: Hi. This is Jeff. I work for Medtronic and earlier you indicated that requests 

for changes to the transition period will be considered on a case by case basis. 

What is the desired method to make this kind of request? Who does a 

manufacturer direct the request to and if the response is going to change and 

the transition period will be made what is the timeframe that we can expect 

before the change is seen in the database?

Jianchao Zeng: So Jeff thank you. So I think I have a quick answer to your question and then 

maybe Scott or Donna can add. So if you have a request for example to extend 

your - a transition period for a specific standard, a vertical standard, product 

specific standard you can send an email to the CDRH standards staff email 
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box or the contact information on the slides so that we can initiate this 

discussion either by email or by meetings so that we are discussing your 

request and wanted to know the justification behind it and then so we will 

understand it better. 

And so basically we wanted to have or maybe consensus between us to see 

what is the appropriate time that we could extend that one year into something

longer? So once the - a decision is made either to for example if we decide to 

extend that one year to another time, so then that would be putting to the next 

recognition cycle because the extent of recognition, change to the extent of 

recognition needs to be published in the Federal Register notice as well. So 

that would be put to next recognition cycle.

We usually have two recognition cycles, one in the spring and the other one in 

the fall. So if the discussion happened during the summer for example, so then 

the result will be reflected in the fall recognition cycle. Does that answer your 

question, Jeff?

Jeff Eggleston: Yes it does, thank you.

Coordinator: We show no further questions at this time. Again if you have a question please 

hit Star 1, record your name. One moment please. 

Next question is from (Mark Swanson). Go ahead. Your line's open.

(Mark Swanson): Hi. This is (Mark Swanson) and I apologize. I think I should know this - the 

answer to this question but I’m not sure. Is there a formal recognition for 

process for TIRs or TRs that goes along with the consensus standards?
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Jianchao Zeng: Yes so (Mark) thank you for that question. So as seen - if you search the 

standards recognition database you would be able to find a few TIR or TR 

Technical Reports or Technical Information Reports in the current recognized 

standards database. 

So although we say that this is a standard database the TIR is not at the same 

level as standard, but some TIRs and some TRs are really helpful for the 

manufactures and other stakeholders. So we also review them for recognition.

Scott Colburn: Yes (Mark) this is...

((Crosstalk))

(Mark Swanson): So some of those TRs and TIRs might be associated directly with the 

application of a standard. Do you need a separate request for recognition of 

those or are those to be reviewed at the same time?

Jianchao Zeng: It’s a separate document so I mean that would be a separate process. But for 

TIRs that are associated with a separate standard, we probably would not 

recognize it as a separate standard that - so it is associated with the standard. 

So we prefer to for example to list it under the guidance and supportive

documentations of the recognition of the standard itself instead of recognizing 

this separately. So that would be probably more useful for the user.

Scott Colburn: And (Mark) this is Scott Colburn. I want to kind of just elaborate on 

Jianchao’s answer a little bit too. Remembering that a standard that is 

recognized under Section 514(c) is one that would be able to be utilized 

towards a declaration of conformity. And we know some TIRs and other types 

of similar documents are more guidance based. They're helpful tools in the use 

of a certain standard.
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So what we do is we first and foremost try to evaluate the document to make 

sure is it something that one that could independently stand on its own 

towards a declaration conformity? And if so it would then make sense to give 

it its own recognition number. If it’s a tool that would help on the 

understanding say of, you know, the risk management or other standards that 

have, you know, documents associated to it, we would reference it underneath 

relevant guidance and work towards that.

One of the things we're actually working to try to do is expand the capabilities 

of our database to maybe even allow a separate page that doesn’t report the 

standard of a "recognized standard" but, you know, a little bit more 

description of that TIR where it would be referenced into other recognized 

standards to give a little bit more explanation for users. But that is something 

that we don’t have yet developed but it's something we're working to do.

But in these types of documents we always want to hear from folks that have 

worked the development or if they think they would be helpful to either on 

their own right or as a part of a recognized standard be used just yes again, 

contact us and we’ll work through that process with you. And, you know, we 

would kind of treat that similar to coming to a, you know, a recognition 

request.

Coordinator: Our next question is from Ronald Reitan. Go ahead. Your line's open.

Ronald Reitan: Yes this is Ronald Reitan again. This is a separate question about the 

application shall we say or declarations of conformity to standards that have 

just been revised and not yet recognized. A classic example of course is as 

you know 60601 family has just undergone revision here in August, 

September October timeframe. And we may have needs to demonstrate 
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conformity to those latest additions before they are recognized, not knowing 

what the shall we say, maximum timeframe is that FDA would recognize 

those updated 60601 standards. Where do you stand when we're in this inbetween zone?

Scott Colburn: So Ron that's the opposite end of a transition question is what do you do...

Ronald Reitan: Yes.

Scott Colburn: ...before a standard is recommended I guess, right?

Ronald Reitan: Yes. And, you know, obviously we have state-of-the-art requirements for 

European MDR submissions as well. And that puts us between somewhat of a 

rock and a hard place on occasion where they’re looking for the state-of-theart standard and maybe FDA has not yet recognized it and we would like to of 

course avoid having two sets of paperwork at all cost.

Scott Colburn: Yes.

Ronald Reitan: So...

Scott Colburn: No I’m - yes, we try to be timely in recognizing standards but realize that we 

also, you know, look at this in batch cycles as well. We are looking at 

standards that we're engaged with and many of the ones you’re referring to we 

are as they publish and discuss it through our process to put it up for 

recognition.

The thing I just wanted to put out first is that, you know, standards are not 

mandatory that are recognized unlike some other jurisdictions. And I, you 

know, while a declaration conformity itself would not necessarily be the 
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appropriate way to identify a new standard not yet recognized, the use of that 

standard itself may be appropriate just because it’s, you know, most likely 

addressing issues of that in more recent and would, you know, tell the story 

that you’re trying to develop in your submission letter.

But, you know, at any time that you are curious as to what agencies interest is 

in particular standard, you can always submit that request in to us. But we do 

try to be timely on standards as they come out. And we are actively looking at, 

you know, the collaterals and the base standards that most recently came out 

in this series to try to determine which ones would be recognizing the 

appropriate transition period, et cetera, et cetera, and we hope to be able to do 

that in a short time.

Ronald Reitan: So a follow-up question there Scott is does FDA have a policy in place as to 

the maximum time from publication of a new standard or a revision to when 

they would issue a decision on recognition?

Scott Colburn: We don’t know. The simple answer is no. And the reason being is we don’t sit 

on every committee. You know, I did a little study a while back. We have 

almost 4000 standards in the medical device community and that’s probably 

still not the correct number. It could be much higher. We obviously don’t sit 

on every one of those committees to have...

Ronald Reitan: Understood.

Scott Colburn: ...the knowledge of that. But what we do try to do is work with our subject 

matter experts throughout the development process of the standard to 

understand when publication will be coming and anticipated recognition 

request or determination by the liaison.
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But we also are interested throughout the development process what issues are 

being raised, how are comments being addressed, are there other avenues that 

we need to consider throughout the development of standards especially some 

of the large impactful ones that might engage with current guidances and other 

things.

So the process of looking at recognition really starts with the engagement with 

that standards development process. And that has allowed us to get 

recognitions out, you know, within a month of standards publication whereas, 

you know, I member a decade ago we were sometimes waiting five, six, seven 

years to recognize a standard because we weren’t engaged in those earlier 

stages.

So I think, you know, you should see a determination coming out, you know, 

hopefully within this calendar year. And if you have further questions too on 

how to apply brand-new standards into, you know, a submission you could 

always try to reach out to that review team, that OHT specific to see how that 

would be best applied. And I think they’d be able to give you a better more 

concrete answer for those particular types of devices.

Ronald Reitan: Thank you.

Coordinator: Our next question is from (Elizabeth Hansen). Go ahead. Your line is open.

(Elizabeth Hansen): Hi. Yes, this is (Elizabeth Hansen). And I guess I just wanted to comment 

on or ask for some clarification I guess with one of the comments that Donna

had made during the - while we we’re waiting for questions and the fact that 

she did say that the Form 3654 was discontinued and that we just go ahead 

and list the standards of conformance in our - on our coverage - on the 3514. 
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When so we do that going forward or when did the 3654 become 

discontinued? Is that with this rollout or what - at what point can we 

discontinue the use of the 3654 and just simply rely on the body of our work 

and the 35 and just rely on the 3514 for listing out our standards, conformance 

of standards?

Donna Walsh: So we still have to, if you’re going to submit a declaration of conformity you 

do you still need to submit that. It's not included as part of Form 3514. I don’t 

know the exact date. Scott do you know when Form 3654 was discontinued?

Scott Colburn: Yes so this was done in conjunction with the more the appropriate use of 

voluntary consensus standards in premarket submission guidance that was 

published on September 14 of 2018, so a little over two years ago. At that 

time that form was officially deleted, removed and we focused on making sure 

people communicated their appropriate uses standards in accordance with the 

publication of that guidance.

Form 3514 actually updated itself about a month or in August of this year. But 

that is the cover sheet form for submissions. It's not a mandatory form...

(Elizabeth Hansen): Right.

Scott Colburn: ...like form 3654. But what we did with that form was, you know, the old 

form only allowed you to list five or six standards and then you had to write 

everything else, you know, on the back sheet of a paper somewhere.

(Elizabeth Hansen): Right.

Scott Colburn: The new form allows you to build out, you know, other standards that you’re 

using, so what standard is it? If it’s recognized what’s the recognition 
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number? If you used it, did you use it towards a declaration conformity or 

general use and where in the submission is that addressed?

And it really is just designed to help people find where and how a standard is 

used. It doesn’t go down the road of, you know, what is your declaration 

conformity look like or things of that nature. We would expect to see that in 

the submission elsewhere based upon the appropriate use guidance. Does that 

help?

(Elizabeth Hansen): Yes I guess so we - but what I’m - what I am hearing about is we're not 

using the 3654 any longer. That’s not the form that we're using. We're simply 

using 3514.

Scott Colburn: Yes and 3514 isn’t really designed for standard. That’s just the standard cover 

sheet form. 3654...

(Elizabeth Hansen): Right.

Scott Colburn: ...was a form dedicated to standards use on standards data that was being 

collected for a different purpose but it was never...

(Elizabeth Hansen): Right. It was used for performance (unintelligible).

((Crosstalk))

Scott Colburn: ...truly appropriately assigned or well understood so that was removed when 

we did the appropriate use guidance in 2018.

(Elizabeth Hansen): Okay. And it was done away with. And so on the appropriate use of 

guidance in 2018 is the...
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Scott Colburn: Yes.

(Elizabeth Hansen): ...(3654) was done away with okay.

Scott Colburn: Yes that was about yes on September 14 of 2018 was when that was kind of 

done in conjunction with that.

(Elizabeth Hansen): Okay.

Scott Colburn: Now...

(Elizabeth Hansen): Okay.

Scott Colburn: ...I'll admit we still do see people using it, but you shouldn’t be able to 

download it really anywhere from the - an FDA site because I don’t believe 

we have it existing in the - anywhere.

(Elizabeth Hansen): In the FDA Web site, okay. I still see it floating around...

Scott Colburn: (Unintelligible).

(Elizabeth Hansen): ...and so I was - I just wanted to double check and then I didn’t - and I 

thought I didn’t know if there was something that was in place of it that I had 

- was using inaccurately or what. So I just want to double check and I heard 

her talking about it so I thought well now's my chance to ask.

Scott Colburn: Thank you.

(Elizabeth Hansen): Okay, thank you guys.
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Donna Walsh: Sure.

Coordinator: We show no further questions in the queue at this time. Again as a reminder 

please press Star 1 on your phone and record your name if you have a 

question. One moment please. 

One moment please. I see a question coming in. And we show no questions at 

this time. I’d like to turn the call over to Irene.

Irene Aihie: Thank you (Dustin). Before I close out Donna, I’m going to turn the call over 

to Donna Walsh.

Donna Walsh: Thank you Irene. Yes, just some closing remarks just to recap. So we - the 

recognition and use of consensus standards is an important element of 

regulatory science at FDA as we’ve discussed today. And our final guidance 

explains the updated procedures that FDA intends to follow when we receive 

requests for recognition of consensus standards and when we withdraw 

recognition of a consensus standard.

So in summary, FDA will publish the rationale for our recognition and nonrecognition decisions. We may specify a transition period for revised 

standards when appropriate. We will intend to respond to recognition requests

within 60 days. And finally, when FDA makes a determination to recognize a 

standard we will update the recognized consensus standards database and at 

that point the standard may be cited in a declaration of conformity.

Manufacturers will no longer have to wait for the official recognition with the 

publication of a Federal Register notice. And there are more information in
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the resources that will be included in the slide deck. And I now turn it back 

over to Irene.

Irene Aihie: Thank you, Donna. This is Irene Aihie. We appreciate your participation and 

thoughtful questions. Today’s presentation and transcripts will be made 

available on the CDRH Learn Web page at www.fda.gov/training/cdrhlearn 

by Friday, October 23. If you have additional questions about today’s 

presentation, please use the contact information provided at the end of the 

slide presentation.

As always, we appreciate your feedback. Following the conclusion of the 

Webinar please complete a short 13-question survey about your FDA CDRH 

Webinar experience. The survey can be found at www.fda.gov/cdrhwebinar 

immediately following the conclusion of today’s live Webinar. The survey is 

also available on the last slide of today’s slide presentation. Again, thank you 

for participating. This concludes today’s Webinar.

Coordinator: That concludes today’s conference. Thank you for participating. You may 

disconnect at this time. Speakers please allow moment of silence and standby 

for your post conference.

END