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FDA Webinar: of Voluntary Consensus Standards; Final Guidance

Moderator: Irene Aihie

October 25, 2018

1:00 pm ET

Coordinator: Good afternoon and thank you all for holding. Your lines have been placed on 

a listen-only mode until the question and answer portion of today’s 

conference. I would like to remind all parties the call is now being recorded. If 

you have any objections, please disconnect at this time. And I would now like 

to turn the all over to Irene Aihie. Thank you. You may begin. 

Irene Aihie:

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

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

available on the CDRH Learn page at ww.fda.gov/training/CDRHLearn, by 

Friday, November 2. 

If you have additional questions about today’s presentation, please use the 

contact information provided at the end of the slide presentation. 

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immediately following the conclusion of today’s live webinar. Again, thank 

you for participating and this concludes today’s webinar. 

Scott Colburn: Hello and welcome to the Appropriate Use of Voluntary Consensus Standards 

in Premarket Submissions for Medical Devices webinar. My name is Scott 

Colburn, Director of the Standards and Conformity Assessment Program. 

Before we start, I want to congratulate all of the staff in CDRH and CBER and 

the many stakeholders who have contributed to this guidance and the many 

areas where scientific research, standards development, conformity 

assessment, and regulatory science intersect. 

Also of note is the publication of our 50th Federal Register Recognition List 

this week that incorporates many of the areas we will discuss today. Also, just 

a few hours ago we recently opened our Accreditation Scheme for Conformity

Assessment Web site that we encourage you to go to and learn a little bit 

about this new draft program that’s taking place under the MDUFA IV 

negotiations. 

I also want to wish everyone a happy belated world standards week that took 

place last week and congratulate the American National Standards Institute on 

its 100th anniversary. It is an exciting time for standards. 

In today’s webinar I’ll be going over the evolution of this guidance document 

from the 2014 draft and the changes that were incorporated in the 2018 final. 

We’ll look at the areas that we discuss regarding the Declarations of 

Conformity, what we talk about when we discuss the ‘General Use’ of 

standards, how FDA does a review of a Declaration of Conformity, and what 

is the supplementary information FDA talks about versus the supporting 
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documentation we receive in how standards are used, and finally well turn 

over to some questions and answers at the end. 

The take home message from stakeholders who commented to the draft 

guidance were for the Agency to follow least burdensome principles when 

requesting test reports, provide consistency across the center with regards to 

data requests, test summaries, or complete test reports, and to provide 

increased transparency about how standards are applied across review offices 

and divisions. 

Of particular concern, reducing paperwork with regards to form 3654 which 

required a form for each standard used within a submission. We have heard 

your comments and will be addressing them and talk about them throughout 

this webinar. 

At the end of the webinar for any type of submission you will be able to 

determine whether or not to provide the Declaration of Conformity or elect to 

use the standard in general use. If you elect the option to provide a 

Declaration of Conformity or DOC, you will learn what elements to provide 

and the supporting documentation to include, if any, or whether to provide a 

complete test report. 

If the option to use the standard is the general way as a reference, you will 

learn also what and when documentation should be included and when it 

should not. 

We are here today to discuss the guidance entitled The Appropriate Use of 

Voluntary Consensus Standards in Premarket Submissions that was issued on 

September 14, 2018. The FR notice of draft guidance was issued on May 13, 

2014 and the guidance proposed two policy changes that were basically the 
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overarching principles discussed in this draft. First was that the Declaration of 

Conformity would no longer be acceptable when the submitter deviated from 

the normative requirements of a recognized consensus standard. The second 

proposal is for promissory statements indicating future conformance with a 

consensus standard to no longer be used in the form of a DOC.

The comment period closed August 22, 2014. 

We received several comments from many stakeholders that included 

standards developing organizations, regulated industry, industry advocacy

groups, and consumer advocacy groups. Some comments related to the first 

policy change, that of deviations within the Declaration of Conformity. Others 

were related to promissory statements specifically requesting to maintain the 

ability to promise within the context of a Declaration of Conformity and 

stating that testing should be done before market. 

Several other comments were in the general category, but we also received 

several regarding the use of Form 3654 being burdensome and how that 

affects the communication of the standards used in the submission as well as 

discussions on transition periods when we do withdrawals to standards that 

are being superseded by new ones recognized.

We’ll be discussing about these different areas of comments throughout the 

rest of this webinar.

With the final guidance we incorporated the 21st Century Cures Act which 

amended section 514(c). We clarified that deviations may be made to a 

standard but not within the context of a Declaration of Conformity. This 

would be general use as described in the guidance. 
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We also clarified our position on promissory statements in that if you choose 

to rely on a recognized standard or a guidance for any part of the device, 

design, or testing you may include either a Declaration of Conformity or a 

statement that testing will be conducted and meets specified acceptance 

criteria before the device is marketed. 

Because the Declaration of Conformity is based on results from testing, we 

believe you cannot properly submit a Declaration of Conformity until you 

have completed the testing the standard describes. For more information, 

please refer to section 514(c)(1)(B) of the act. 

We adopted for use ISO/IEC 17050-1 and -2 which clarifies the content of a 

Declaration of Conformity and the accompanied supporting documentation 

that underpins the extent of Conformity and how it was assessed. Also, we are 

now also including the transition period for all standards that are withdrawn 

and replaced with newer version. 

Lastly, form 3654 is eliminated because the elements of the form are 

addressed by the Declaration of Conformity that we’ll be discussing as 

outlined in ISO/IEC 17050-1 and -2

The 21st Century Cures Act of 2016 (Pub. L. 114-255) modified Section 

514(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to clarify 

how the FDA will process requests for recognition of voluntary consensus 

standards. Any interested party may submit a request for recognition of an 

appropriate standard established by a nationally or internationally recognized 

standard development organization. Specific changes included:

adding a 60-day timeframe for FDA’s response to recognition requests, 

directing FDA to publish on its website its rationale for recognition of all, 

part, or none of a standard that is subject of the request and issue a statement 

to the requester of its rationale for that determination. The statement will 
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include the scientific, technical, regulatory, or other basis for the 

determination, requiring training for all FDA reviewers of premarket 

submissions, and requiring FDA to provide periodic training on standards.

Of note, FDA has a draft guidance document titled Recognition and 

Withdrawal of Voluntary Consensus Standards that is open for comments 

until November 13, 2018, where much of this is outlined. 

So what is a Declaration of Conformity or DOC? The DOC is an attestation 

from the submitter that the device conforms to all the requirements of an FDA 

recognized consensus standard at the time of submission. If the submitter 

declares Conformity to an FDA recognized standard, a Declaration of 

Conformity must be included in the premarket submission. 

The purpose of a Declaration of Conformity is to reduce the amount of 

supplemental data and information that is submitted to FDA.

So what does this mean? FDA expects that all testing required by the 

consensus standard will be performed and conformance to the consensus 

standard will be met before premarket submission. All normative 

requirements have been met and most testing conducted on a finished device 

or a final finished device. 

In the past, the composition of a Declaration of Conformity was based on 

ISO/IEC Guide 22 which is no longer in publication and has been updated and 

replaced by ISO/IEC 17050-1 and -2. 

What is a finished device? Under 21 CFR 802.3(l), a Finished Device is “Any 

device or accessory to any device that is suitable for use or capable of 

functioning, whether or not it is packaged, labeled, or sterilized.” A Final 

Finished Device is any device that includes all manufacturing processes for 
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the “to be marketed” device, including packaging and sterilization, if 

applicable.

Everything you need is here. The Declaration of Conformity should include 

these elements: 

• name and address of the applicant or sponsor responsible for the 

Declaration of Conformity

• the product or device identification

• the Statement of Conformity

• a list of standards or which the Declaration of Conformity applies 

including, for each standard, and the options selected if any

• the FDA recognition number for each standard. Remember, you can only 

submit a Declaration of Conformity to a recognized standard by FDA

• the date and place of issuance of the Declaration,

• signature, printed name, and function of the applicant or sponsor 

responsible for the Declaration of Conformity, and

• any limitation on the validity of the Declaration of Conformity. 

o For example, how long the Declaration is valid, what was tested, or 

concessions made about the testing outcomes. 

If you really think about it, the only change that we have placed into the new 

guidance is listing the recognition number of the standard you’re submitting in 

your Declaration of Conformity. Everything else has remained the same since 

the previous guidance.

The next few slides are examples of what Declarations of Conformity may 

look like. And there are other examples out there as well. But one here shows 

everything that you would be presenting. The Declaration of Conformity calls 

out the elements of 17050-1, gives the name and address of the sponsor, the 

product and the device identification, the statement of Conformity, and lists 

the standards for which the Declaration of Conformity applies. 
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Here you see the recognition numbers, the date and place of issuance, and the 

signature and printed name as well as any limitations on the validity of the 

Declaration. 

Alternatively, I’d like to show you another example. Here you’ll see we also 

have the Declaration of Conformity to IEC 60601-2-37 under the recognition 

number of 12-293. But you’ll see that the two other collateral standards of 

IEC 60606-1 or in the case of FDA’s recognition the ANSI/AAMI ES60601-1 

and the IEC 60601-1-2 are not included. 

If you think of how the body of standards work with the particulars in the 

60601 family, there’s no need to include the other normative standards 

separately as they are already called out as being requirements that satisfy the 

vertical standard. 

This is an example different ways one can present the Declaration of 

Conformity discussing the different manner to which a particular standard 

incorporates other normative references and/or recognized standards. 

Now I will note and I am aware that the ANIS/AAMI ES 60601-1 standard is 

not normatively placed as a requirement in [60601]-2-37. However, FDA only 

recognized the ANSI/AAMI ES version and therefore FDA would expect that 

testing conducted to meet that normative requirement in the particular would 

be that of the recognized version of the standard. 

Normative references -- Why are normative references used in consensus 

standards? Simply put, the use of normative references promotes 

harmonization and saves resources, referencing common elements, promotes 

uniformity or requirements and avoids the inevitable divergence of 
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requirements that result when different groups of experts develop solutions to 

common problems. 

Using normative references in an FDA recognized consensus standard 

towards Declaration of Conformity can reduce the amount of documentation. 

Maybe less obvious is the savings in human resources as well. Smart 

standards writers did not reinvent the wheel; they use current standards to help 

the normative requirements in their existing standard. They reuse what is best 

in existing standards and that apply to the particular situation through the use 

of normative references. 

So what do we mean by a normative reference in a consensus standard? 

Again, consensus standards generally have two type of references. First they 

have a bibliography which consists of informative references that are useful in 

understanding the requirements of the standard and may be used in 

conjunction with the standard.

Second, consensus standards may contain a section that details designated 

normative references. In ISO and IEC standards, normative references are 

listed usually in clause two of the standard. The purpose of normative 

references is stated in the boilerplate used for references – “The following 

reference of documents are indispensable for the application of this 

document.”

This simple statement does not say that the entire reference standard or 

standards must be used in order to demonstrate Conformity to the standard. It 

merely states that you can’t apply the standard without the knowledge and 

appropriate use of these normative references. Plus, the difference between an 

informative reference and a normative reference in a consensus standard s that 

you’re free to refer to the former, but you must refer to the latter.
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How do requirements of a normative reference get incorporated into the 

requirements of a consensus standard? In order to incorporate the 

requirements of a normative reference into the requirements of a consensus 

standard, those requirements must be referenced within the body or normative 

section of the consensus standard. Thus the normative reference made at the 

introductory part of the consensus standard is a precursor to the statement that 

the actually normatively referenced requirement stated later on. 

Once such a reference is made in the body of the standard, Conformity to the 

standard includes a requirement cited in the normative reference as well as the 

stated requirements of the consensus standard. 

So do all the requirements of the normative reference apply? Again, and 

discussed a little bit earlier, the use of normative references is usually limited 

to that specific clause or clauses that are necessary to achieve the goals of the 

consensus standard they are normatively referenced into. In some cases, just a 

single clause will be incorporated into the requirements of a consensus 

standard. 

In some others, the normative references are incorporated in its entirety. It is 

important to note that the user, tester, manufacturer, as well as the reviewer of 

a Declaration of Conformity and test reports understand how the normative 

references apply to the standard which the Declaration of Conformity is being 

submitted. 

So does FDA recognition of a standard mean that all the normative references 

are automatically recognized? No. Normative references are recognized by 

FDA only to the extent that they are used within the FDA recognized 

standard. Such normative standards are not automatically recognized as 
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independent entities unless it is felt that independently the use of those 

standards would also be useful to support the relevant parts of the Act under 

514(c). 

Knowledge of the normative reference should be used to apply a recognized 

standard. Normative references do not typically reference the entire standard. 

Rather, the normative references are typically limited to a specific clause or 

clauses. The citation of the normative reference should provide information on 

the extent the reference is limited or applied. 

So as we all remember back in the 80s the statement “Where’s the beef?”

When we’re talking about a Declaration of Conformity, ISO/IEC 17050-2 

Conformity assessment part two - Supplier’s Declaration of Conformity, the 

supporting documentation sets forth the requirements for documentation to 

substantiate a Declaration of Conformity. 

There are circumstances when supplemental documentation is necessary to 

support a DOC or Declaration of Conformity. The type of information a 

sponsor should submit and the FDA needs to review as supplemental 

documentation will vary based upon the specific consensus standard. 

However, the following general principles should govern the need for and 

review of supplemental documentation. At a minimum, the following 

questions should be asked of the standard -- a description of the object under 

test and whether that is a final device, final finished device, or an attribute of 

the device; a description of the test method or procedure and whether Good 

Laboratory Practices or Quality System Regulations were followed; the results 

of the testing and acceptance criteria; and an assessment and results of how 

the normative requirements were met, including rationales for any selection, 

adaptations, modifications, or concessions that were made. 
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So what is the difference between a Supplementary Information Sheet and 

supplemental documentation to a Declaration of Conformity? The 

supplementary information sheet is CDRH’s determination of how the 

recognized standard may be used in CDRH’s regulatory activities. For 

example, a supplementary information sheet or SIS may describe the select 

the sections or clauses in the standard that are excluded from FDA’s 

recognition.

Supplemental documentation describes how the medical device conforms to 

the FDA recognized standard. For example, supplemental documentation may 

describe the acceptance criteria and rationale for selecting those criteria to 

demonstrate the essential performance of a medical device. 

Specific guidelines exist to help determine whether or not supporting 

information should accompany a Declaration of Conformity. 

Supporting information should accompany a Declaration of Conformity when:

• an FDR recognized consensus standard describes a test procedure but does 

not include performance limits or pass fail criteria. The submitter should 

provide an assessment of the results and how Conformity was determined, 

When the FDA recognized consensus standard includes choices related to 

for example, what is to be tested, which test methods to use, or the 

performance limits to test Conformity, or when it describes a process like 

risk assessment, the submitter should include an explanation for those 

choices and the selections made. 

Supporting information should not accompany a Declaration of Conformity

when: the FDA-recognized consensus standard includes both a test method or 

procedure with the predefined performance limits or acceptance criteria. 
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FDA should not request the data related to the specific consensus standard 

identified in the Declaration of Conformity when those exist. When there is 

more than one standard, for example -- one a test method and one with 

acceptance criteria -- or when the FDA recognized consensus standard is a 

design standard. These are the areas to which a Declaration of Conformity by 

itself under ISO/IEC 17050-1 should meet the required elements to support 

the Declaration. 

During review of a premarket submission in which a Declaration of 

Conformity as been submitted, FDA will review the Declaration of 

Conformity and determine whether the following have been met: 

- the elements in this guidance as well as ISO/IEC 17050-1 are present,

- the standard or standards identified in the Declaration of Conformity are 

recognized consensus standards, 

- there have been no deviations made to the normative requirements of the 

FDA recognized standard identified, 

- the FDA recognized standard in the Declaration of Conformity are or is 

applicable to the medical device under review, 

- the supporting documentation - if determined to be necessary per ISO 

17050-1 - is provided according to ISO 17050-2 or equivalent,

- the data or information submitted to support such Declaration

demonstrates that the device is in Conformity with the normative 

requirements of the standard, 

- the Declaration of Conformity does not include a promissory statement. 

If any of the elements above are not met, FDA will review any explanation 

provided by the sponsor to determine if it is adequate to support the 

Declaration of Conformity or may request additional information to meet 

those requirements. 
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So why Can FDA Rely on a DOC? Let’s talk about the reasons we can rely 

on the Declaration of Conformity. We know Declaration of Conformity is an 

official statement and falsification of a Declaration of Conformity submitted 

under section 514(c) of the FD&C Act is a prohibited act. 

Under section 501(e)(2) of the FD&C Act, a device is adulterated if, among 

other conditions, it is declared to be in conformity with a recognized 

consensus standard unless the device is in all respects in conformity with such 

standard. 21 CFR Part 58 Good Laboratory Practices establishes quality and 

reliability of how labs will conduct non-clinical laboratory testing. 

The Quality system regulation in 21 CFR part 820, by which a manufacturer 

must also establish and maintain procedures for validating a device design and 

monitoring and control of process parameters for validated processes to ensure 

that the specified requirements continue to be met.

By note, this is also similar to requirements in other quality system standards 

such as ISO 13485. 

And laboratory accreditation under ISO/IEC 17025, ISO/IEC 17043, and 

other areas within the ISO/IEC 17000 series as well as ISO 15189 for clinical 

laboratories -- these series of standards set forth a system for how labs will be 

operating when they are accredited through these schemes and how it supports 

the adequacy of a Declaration of Conformity.

So let’s talk a little bit about complete test reports. Complete test reports are 

requested when a Declaration of Conformity is not provided or the standard 

has neither test methods or predefined acceptance criteria or deviations have 

been made to the recognized standard. In any of these situations, FDA would 

expect to see a complete test report so that it could understand those 

adaptations or modifications to testing in the product or device. 
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This table from the guidance document outlines FDA’s expectations regarding 

submission of supplemental information for different types of FDA 

recognized consensus standards. Use this table during your reviews or the 

submission and development of your submissions to help indicate that 

supplemental information that may be necessary to support how you’re 

appropriately using the standards. 

‘General use’ of a consensus standard in premarket submissions is when a 

submitter chooses to conform to a consensus standard in part or in whole, but 

does not submit a Declaration of Conformity. 

Reasons for general use of a consensus standard vary but may include: the 

manufacturer’s chosen to use a recognized standard without submitting the 

Declaration of Conformity; the manufacturer has deviated from the FDA 

recognized consensus standard methodology to adapt its purpose to test the 

device, or the manufacturer has chosen to use a non-recognized consensus 

standard or an older version of the standard that is no longer recognized.

Standards may change before, during, or after review and this is where we talk 

a lot about transition. Before review [of a submission], standards may be 

updated or revised and the newer version recognized during product 

development. This may present challenges to submitters. FDA values and 

encourages early interaction with submitters to ensure scientific issues are 

addressed prior to the submission of a marketing application for a device, 

including the discussion of the changing standard. 

The submitter is encouraged to engage with the agency regarding the strategy 

for addressing the differences between the two standard versions and whether 

those differences significantly affect the evaluation of safety and 

effectiveness. This is because it may not be necessary to comply with all parts 
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of the revised standard, only those parts that significantly affect the evaluation 

of safety and effectiveness.

During review: Generally while a submission is undergoing active review and 

in the interim, a consensus standard is updated or revised and recognized, 

FDA will continue to review that submission based upon the previously 

recognized version.

If the updated or revised consensus standard addresses a new safety or 

effectiveness issue that is relevant to the final decision of that submission, and 

if that information is not described elsewhere in the submission, FDA may ask 

the submitter to either meet the portions of the new or updated standard that 

addresses that safety or effectiveness issue, or provide alternative data or 

information along with scientific rationale for why the alternative addresses 

the issue. 

After review, just as standards may be revised before submission they most 

certainly will be revised after clearance or approval is granted. Changes in the 

recognized consensus standard do not retroactively affect the product’s 

clearance or approval status. 

Similarly, once a consensus standard is recognized, recognition of its revisions 

is not automatic. In general, FDA actively assesses the impact of new 

consensus standards and revisions of existing standards on the premarket 

review process and recognizes these standards as appropriate. As new or 

revised standards are recognized by FDA, the recognition will be published in 

the Federal Register and listed on the CDRH Web site. 

FDA performs the activity twice annually or more often. Superseded 

standards that FDA has withdrawn from the list of recognized standards 
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cannot be subsequently used towards a Declaration of Conformity. If a 

submitter receives clearance or approval based in part on the Declaration of 

Conformity, but the standard is withdrawn from recognition, the cleared or 

approved device remains legally marketed and remains eligible for 510(k)s as 

a predicate device. 

However, any new device citing such predicate in a 510(k) submission cannot 

similarly rely on the Declaration of Conformity to the standard no longer 

recognized. In these circumstances, FDA would likely recommend that the 

submission use the newer, currently-recognized version. 

Which brings us to transition periods. As we discussed three areas where 

transitions could apply to the premarket review. [FDA] looks at transition 

periods where standards have been withdrawn and replaced by newer 

versions. We look at the impact of that standard and try to specify the amount 

of time to which the outgoing standard should remain, in effect, a recognized 

standard until it is officially withdrawn. That information is contained in the 

Supplementary Information Sheet or SIS below the extent of recognition. 

Standards that do impact large broad areas such as the Quality Systems 

Regulations or other major horizontal processes will typically receive a longer 

two to three year transition. We also do consider the ISO/IEC implementation 

withdrawal dates listed or if other standard developing organizations make 

recommendations and try to take other information that is available to the 

Agency to take into account the impact or a transition period during the 

recognition of a newer standard. 

Why? This allows a submitter to continue to test and develop without 

additional retesting, allows time to revalidate processes under 21 CFR 

820.75(b), and allows testing laboratories time to revalidate new test methods.
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A promissory statement or note is defined as a statement in which the 

submitter indicates that the device is not yet known to be in conformance with 

consensus standards at the time of the premarket submission but will conform 

to the consensus standard before marketing. Promissory notes are used in 

certain situations such as installation requirements, chronic or long-term 

testing or postmarket testing. 

Although a promissory statement describes a situation where a submitter 

states that they will conform to a recognized consensus standard in the future, 

submitters may not use a Declaration of Conformity with a promissory 

statement. I’ll say that again. Submitters may not use a Declaration of 

Conformity under 514c with a promissory statement. Submitters may only use 

a Declaration of Conformity to a recognized standard if conformance has been

met prior to the submission. 

Pending recognitions and the intent to recognize -- this is something new that 

we introduced to this guidance document. Within this guidance, FDA has 

declared its intent to recognize a standard when the Recognized Standard’s 

Database is updated. The database is refreshed once a week usually. The 

Standards and Conformity Assessment Program will update the database 

when the sender has developed a Supplementary Information Sheet (SIS) to a 

newly recognized standard that the Agency intends to recognize. And will 

include a recognition number so stakeholders can begin to use the standard. 

A list of pending recognitions will be included in the subsequent upcoming 

Federal Register Notice that we put out once or twice a year. 

The dates of standard is entered into the recognition database. It is the 

effective date of recognition that you would apply in the use of that standard. 
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This slide is just a list of resources that are utilized by both the CDRH

Standards and Conformity Assessment Program as well as the agency’s use of 

standards and across the federal government. 

At this time, this concludes the content in the webinar. I want to thank 

everyone for joining and I guess we will open up for questions. 

Coordinator: Thank you. And at this time if you would like to ask a question, please press 

star 1. Please unmute your phone and record your name clearly when 

prompted. And if you would like to ask a question, please press star 1. One 

moment please. 

Scott Colburn: So while we are waiting for the first question, some of the questions that come 

in have been regarding transition and when we put out a transition dates that 

we listed on the most recent recognition list that came out on this week 

regarding transitions of 12 months for certain standards.

And I’ll be quite frank and transparent with you. This is an area that we are 

still building a base of knowledge to help understand the impact and do 

encourage stakeholders to contact us if they feel the transition date that was 

selected may not follow the principles that we have in our guidance. 

We understand that many cases standards that are vertical based or product 

specific, in our eyes, tend to possibly require less time for appropriate 

transitions. But we also may not take into account some of the research and 

development activities that are going on at the early stages of the design 

control process. Information like that is helpful in our understanding of 

applying the appropriate amount of transition applied. That is one area that I 

think is real important.
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Another one is where standards have been updated that are not yet cited in the 

parent standard where a ‘Declaration’ is being submitted -- and I discussed 

this a little bit. It is appropriate to use a newer standard, say an ASTM test 

method that specifies the durometer on how would you assess the hardness of 

a material, that is not yet incorporated into a product specific standard and a 

new version of that test method has come out? Can you utilize that test 

method and still be in conformance with the recognized standard? 

This is one of those where it does depend and you need to make sure you 

assess the impact of the newer standard and the use of that newer standard and 

where its normative references are incorporated appropriately still meet the 

requirements of the standard to which you are submitting a Declaration of 

Conformity or the general use to. 

And so these are just a few examples of how you can make that assessment 

because, as we know, normative references that exist in a parent standard may 

be updated during the course of or immediately after the publication of 

another standard and that test laboratories -- especially those in the accredited 

environments -- may be using those newer standards to maintain the current 

state of art or practices that are currently being utilized at that time. 

So I will pause to see if we have any questions. 

Coordinator: And as a reminder to ask a question please press star 1. Our first question 

today is from (Vivian). 

(Vivian): Hi. My question again is related to the transition period. So when a revision of 

an existing standard is out there, I see you know that a transition period is 

posted in the location that you mentioned. But when it’s a brand-new standard 
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that gets, you know, recognized is it -- I’m trying to understand -- is it the 

expectation that from the time it gets posted from that date that you know we 

would start showing compliance? Or what the expectation from a transition 

period is for new standards that come.

Scott Colburn: So (Vivian) I’ll try to answer the question from two different directions. And 

one would be if you are developing a new product that would require FDA to 

evaluate. Standards first and foremost that are recognized, are voluntary, and 

are not requirements. We feel that they are tools that are suitable to help tell 

the story of what you are trying to explain in your submissions. So the use of 

them are voluntary.

But when a new standard does become recognized, we do hope that 

manufacturers will use them as appropriate to support their submissions that 

are coming in. So that would be one away to help and I think create a common 

line of understanding between the review staff who are familiar with the 

standards that are recognized and what would be coming in. 

The second side of that question though is -- and I received a similar question 

on this just this week from a manufacturer -- is what happens to a legacy 

product when the new standard is being recognized and are we expected to be 

in conformance of that [newly recognized]standard?

And I believe I described that earlier in this webinar where a legacy product is 

not required to have to demonstrate to the agency that you have updated your 

file to the newer standard. However, I do note that in many cases the Quality 

System Regulations and/or quality system standards do ask for a process 

improvement or quality improvement where you do assess newer 

standards/methods to see if you’re maintaining the state of art activities that 

would support the quality of a device. 
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(Vivian): Okay. Thank you.

Scott Colburn: Next question?

Coordinator: Thank you. Our next question is from (Eric Kellnas).

(Eric Kellnas): Hi. This is (Eric). Thank you. For 510(k)s I just would like to confirm that the 

Form 3654 is no longer required and would not be looked for under the review 

to accept criteria. And they would just be looking for, you know, the DOC and 

supporting evidence. Thank you. 

Scott Colburn: Yes, thank you (Eric). I’ve been looking forward to repeating that question as 

many times as I can! We’ve been talking about Form 3654 since the 

development of this guidance. So yes, Form 3654 has been deleted. It is no 

longer on the RTA -- refuse to accept checklist -- that I think was updated 

2016 where it removed that requirement and well as in this guidance. 

Because we had seen so many different ways the form had been utilized, and 

its intent was actually never fully incorporated to collect standards data the 

way it was when first developed. The form has hence been deleted and we are 

recommending that you just clearly identify through the tools in this guidance 

whether it be a Declaration of Conformity or citing the standard in its general 

use or even using tools such as Form 3514, which is the cover sheet and has 

an area which you can outline what standards are being used. Those are the 

areas that will give the information that should be sufficient enough for the 

review staff to understand how/where the standard is being used. 

So in short, no the form is no longer required and I even tried to look for it 

online and I couldn’t find it!
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(Eric Kellnas): Excellent. Thank you. 

Coordinator: Thank you.

((Crosstalk))

Coordinator: The next question is from (Andy During).

(Andy During): Yes, good morning Scott. Thank you very much. My question -- the 

committees that I’m participating in have had and continue to have 

representation from the FDA helping to shape the standard as it’s being 

developed. So I’m wondering one, would that participation on a committee 

still necessitate somebody requesting the standard be recognized or could we 

assume that the goal is to recognize that standard -- the goal of participation 

and consensus with the content would be to FDA recognize the standard? 

Scott Colburn: That’s a great question, (Andy). And that serves a number of purposes. So 

yes, as many people know we do participate on several working groups and 

committees across almost three dozen standard developing organizations. I 

think on a little over 600 different working groups. But we don’t know all 

standards that are being developed. 

And as technology is being broadened and we’re looking into areas such as, 

artificial intelligence and other areas like nanotechnology or cybersecurity, 

those are the areas that we don’t typically have personnel or expertise to be 

involved in all those standards. And they may be appropriate for requesting a 

consideration to recognition. Those are the ones that we typically hope to hear 

from our stakeholders on considering for recognition. 
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Where we do have participation, one of the roles and responsibilities for us is 

to receive continuous feedback throughout the development of a standard that 

would help formulate the appropriate recognition and we hope that 

engagement with the standards organization will take place of that. 

Now, we are not, a speedy jackrabbit or anything so you may not see 

immediately upon publication within the next week or two the intent to 

recognize through the database, but if you don’t see anything for maybe a few 

months, feel free to contact us. But it does take time for us to go through the 

internal process to make sure we are making the appropriate decisions before 

we would go out with the intent to recognize the standard. 

We are hopeful that we won’t need to receive for every committee we’re 

sitting on, additional requests for recognition in that realm. 

(Andy During): Okay. Thank you. And can I follow up? Just wondering if that participation 

would also lead to a fewer parts of a standard that may not be included in the 

recognition. I mean, if we’re actively participating and there’s a general 

consensus on the content, would we expect the standard to be likely 

recognized in full? 

Scott Colburn: Well, that’s obviously the main goal of participating in standards so FDA can 

provide the perspective into the committee. But as you know, standards are 

consensus based and maybe the issues that were brought forth by the agency 

didn’t override the consensus of the group. 

And there are cases where if we have existing guidance or regulations and the 

content of a standard, especially international or global standards, may not be 

in alignment with current policies we have in place. And that’s where you’ll 

more likely see potential [partial] extents of recognition but we would be 
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pointing for the rationale for such partial recognition to an existing policy or 

regulation or guidance document that would help show where you would go to 

satisfy that section that is not recognized. 

But to your point, the goal is always to try to build an internal level of 

understanding to what we can bring forward to the committee to help address 

those issues in the hopes of having a complete recognition. 

Just as a statistic note, out of the over 1,200 standards we recognized, I think 

there’s around 130 -- give or take -- standards that we have a partial 

recognition on. So that is not the norm to have partials. It’s more the 

exception.

(Andy During): Thank you, sir.

Coordinator: Thank you. Our next question comes from (Jenny Foo).

(Jenny Foo): Hi, Scott. I just had a question about the use of ISO-IEC 17050 in regards to 

the Declaration of Conformity. Do you actually list that standard itself on your 

Declaration of Conformity? 

Scott Colburn: No, we don’t. I mean, and I believe every whenever I go on Google and 

search what is the Declaration of Conformity, they all follow - this template. 

It’s a guide to the elements of a Declaration of Conformity. 

It follows virtually identical to what has always been conducted. Even when 

this program kicked off in 1997 using ISO Guide 22, this guide just came in to 

become ISO/IEC 17050-1 and then the supplemental information or 

supporting documentation in the -2. 
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You don’t need to dictate that (use of ISO/IEC 17050). The review staff will 

be looking at the appropriate elements to ensure a Declaration of Conformity

has met those necessary factors we outline, but if you just follow the guidance 

and the content, that should be more than satisfactory.

(Jenny Foo): Okay, good. I thought that would be kind of obvious but I just wanted to 

double check. Thank you. 

Scott Colburn: The goal has not changed. Really the one major change I would say -- and it’s 

not a major change. It’s just a very helpful tool and it also allows us to receive 

some metrics of understanding -- is adding the recognition number of the 

standard that you are listing on the Declaration and that allows us to make 

sure and get us to a quicker resolution that the appropriate standard was 

selected towards the purpose of a Declaration. 

Coordinator: Thank you. Our next question is from (James Hanes). And please limit 

yourself to one question. 

(James Hanes): Hi Scott. Good afternoon. This is (James Hanes). My question is in regards to 

the applicability of the consensus standards to drug device combination 

products. 

We work with products that are regulated a drugs and are reviewed by 

(CDER) and (CBER). And was wondering if this could be applicable to the 

device constituent portion of the combination product. Thank you. 

Scott Colburn: Yes. So (James), great question. Thanks for the easy one. So with the use of 

standards in combination products, I would first recommend discussing this 

with who the lead center is of review and deciding, if it’s s (CDER) led review 

versus CDRH review to get that question answered up front. 
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Obviously if it’s a CDRH level review or lead review and you’re using 

standards towards a Declaration of Conformity, this guidance applies directly. 

Although we do have great relationships with the majority of the areas where 

combination products are interfaced (with the use of standards) and we’re 

doing consultative reviews and standards may apply, the level of information 

of supporting documentation may vary based upon the type of document that 

you are submitting and that is being reviewed. 

And I would first recommend that if the lead center is not CDRH always ask 

the question if you do know who is working on that part from the CDER side, 

because I don’t want to speak for CDER and their policies as they too are also 

looking at how they can benefit from use of standards. So I think a lot of 

principles do seem to apply, in many cases across different areas of the 

agency. However, it’s always best to start with the primary center and the 

review team to ask those questions upfront.

Coordinator: Thank you. Our next question is from (Lauren). 

(Lauren): Hi. Yes, I’d like to ask if there is a consensus - excuse me, if there is a 

recognized standard for your product but there are some elements of that are 

not applicable, can you issue a Declaration of Conformity and then have the 

justification in the report that you have? Or do you have to do it in an alternate 

way? 

Scott Colburn: So just to make sure I understand the question correct, it’s when you are 

utilizing a particular standard but not all elements of that standard apply, can 

you still submit a Declaration of Conformity? And I think I can give the 

general answer but I think you may want to always feel free to ask that 
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question of the review branch or review team that is in that - may have a little 

more knowledge on a particular standard. 

In general, many standards may be designed in a way that you have to use

selections or use certain options based upon the technology of the product that 

you are testing under. Certain areas may not be applicable, and in your 

Declaration what you may want to provide is the justification that would 

dictate why a certain section was not applicable and provide the appropriate 

justification to that as well. That would be the key in understanding why you 

didn’t test to a certain subclause or normative requirement in the standard 

simply because the design or technological features based upon your device. 

(Lauren): Thank you. 

Coordinator: Thank you. Our next question is from (Christina Hart).

(Christina Hart): Hi. What is the role of recognized consensus standards for items that are listed 

as 510(k) exempt? 

Scott Colburn: So we in general I know the culture’s always been thought of in terms of 

recognized standards are for those that are only ones that we would receive 

submissions on. But in actuality that isn’t a true fact. 

We do recognize standards for many devices that are exempt from regulation -

- not regulation, but are 510(k) exempt. Both in the class one and class two 

areas. 

One example I always give is the hospital bed standard. IEC (60601)-2-52 is a 

recognized standard. I think that’s the correct number. We did that because we 

also knew that there was some areas in the post market domain that we were 
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seeing adverse events on, whether it was bed entrapment or hospital bed fires. 

Subject matter experts and regulators went and worked with the IEC 

maintenance team to update the standard to help address those areas. We also 

felt that it was important for us to indicate that the standard is important and 

should be considered, obviously still under a voluntary basis, but as a 

recognized standard. 

And so you will see several standards that we do list that may be to exempt 

510(k) type devices. And, the manufacturers have the option if they so choose 

to utilize those standards to support or consider what would be appropriate for 

use when testing. 

(Christina Hart): Thank you. 

Coordinator: Thank you. Our next question is from (Leonard Eisner).

(Leonard Isner): Hi, Scott. So I’ve got a specific question around some of the 601 series of 

standards of medical electrical equipment. So (60601)-2-18 which is 

endoscopic systems is recognized for an older - it aligns with 601-1 third 

edition which is not recognized because amendment 3.1 is recognized. Also, 

there is reference to 2-2 which is the high frequency surgical standard and 

that’s an older version as well because 2-18 was released in 2009. And it’s not 

going to be updated probably until the end of 2019 or so from what can I tell. 

So how do you approach that when you have all these major alignments 

issues? Because what I was told by someone in the group of standards and 

Conformity assessment is you can write a Declaration but you need to 

basically do a gap analysis for the difference between the third edition’s 3.1 

and 601-1, et cetera. And sometimes the alignment of those standards in the 
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601 series between one addition and another gets sort of tricky because some 

elements disappear, some are (unintelligible), et cetera. 

Scott Colburn: Thank you, (Leo). I was hoping you’d keep talking to me to answer the 

question that you asked. I do appreciate the question though. And the 601 

series is the animal of all animals because it has such a large, broad base of 

particulars that reference so many collateral standards that at different times 

are being updated. And this kind of goes into the earlier question of how do 

you appropriately use the normative references -- especially when some of 

those normative references may have newer versions of FDA recognized 

consensus standards. 

And I think sometimes, there’s a two-way approach of how you look at it. If

an FDA recognized consensus standard has older normative references a 

Declaration of Conformity based upon the outline of that standard can still 

apply. However, as I state in many presentations, conformance does not equal 

equivalence; Conformance does not equal approval. And the use of standards 

typically does not fill the entire mosaic picture that you’re trying to create. 

There are still gaps in that. 

So what is important is for you to look at that, and in the case of 601 to see 

how does that meet your essential performance. How does that satisfy the 

risks that you’re trying to mitigate in your risk analysis? And is using some of 

the newer standards help get you closer to those areas where the gap may be 

less if you use the newer version of a standard?

The key thing here is -- and you’ll see this theme through every question now 

if you kind of look back in the recording -- is to make sure that you are 

appropriately connecting with your review team because they will be able to 
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help give you what they feel would be the most reasonable and least 

burdensome approach to looking at that question.

Using the newer standards a lot of times does address newer issues that have 

come up whether it be through postmarket analysis and other areas where we 

have seen improvements in technology. And (those updates) just have not yet 

hit the newer particular standard in this case. But it doesn’t preclude you from 

being able to utilize that newer standard if that does help you in making your 

story about how you have addressed certain areas of risk.

So the most important thing would be making sure that your submission in 

totality addresses the areas that are going to be of concern for you to be able to 

get your clearance or approval as appropriate. And how you utilize some of 

the normative references when a newer version may exist may be a way for 

you to help limit some of the amount of information that would have to 

accompany that Declaration. But when you are using different normative 

references or updated references, it will be very important for you to clearly 

outline why you did that so that it is clear to the review team when they are 

assessing the overall submission. 

Coordinator: Thank you. Our next question is from (Debbie Brown).

(Debbie Brown): Thank you so much. My question was already answered. 

Scott Colburn: I’m very glad to hear that, (Debbie).

Irene Aihie: We’ll take our next question. 

Scott Colburn: Yes.
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Irene Aihie: Operator, are you there? 

Coordinator: I am. Our next question is from (Hugh).

(Hugh): Hi. On your sample Declaration of conformance you did not list the dates of 

revisions of the standards. And I bring that up because there are times when 

the standard recognized by the FDA is an older version than the one 

recognized by other regulatory bodies such as Europe. And when we’re trying 

to satisfy regulatory bodies in different geographies, how should we go about 

declaring a conformance? Should we try to declare a conformance to the 

newer one? Would the FDA accept that? 

Scott Colburn: Yes, that’s a great question. Actually kind of a good catch here. Could the 

Declaration of Conformity be a little bit clearer by adding the date? I think in 

the case when we drew up this example if you look at a particular recognition 

number, that recognition number does tell out a specific version of that 

standard and in that the date of the standard is incorporated to that recognition. 

So it is in fact kind of built into the Declaration appropriately that way.

Can you also add the date to the standard? Yes. But what we really want to 

make sure too is that you are using the appropriate standard to the version that 

is recognized and not using an older version of a standard to the version that is 

recognized. 

So the driving tag here really is the recognition number, which will call out 

the version of the standard to which the Declaration would be expected to be 

read from. Does that help?
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(Hugh): Yes. I guess the only thing is if Europe is requiring or requesting a newer 

version and the FDA recognizes the older version, it kind of puts 

manufacturers in a little bit of a bind. 

Scott Colburn: So if there’s good way to talk about the draft guidance that’s out on the 

recognition and withdrawal of (voluntary consensus) standards and where we 

do have the opportunity for stakeholders to request for recognition of the 

agency a standard that you yet have not seen the newer version of. 

And as I mentioned to (Andy) earlier, while we’re on several committees and 

we try to keep our eye on all the areas where standards development takes 

place, we don’t get that tag notification or poke sometimes until we do receive 

that from a stakeholder. So if you feel it would be helpful to have a newer 

version recognized, by all means feel free to contact the agency. And we have 

that information on how to do that both in the draft guidance of course, but 

also in our Web site it also indicates how you can contact the standards 

program. 

Coordinator: Thank you. Our next question is from (Allison). 

(Allison): Hi. I just want to echo a collective hooray for the end of Form 3654 so thank 

you for that. But my question is more with best practices and if the FDA has 

any guidance on how the medical device manufacturers can work together 

with their test labs to come up with a Declaration of Conformity. I know that 

the manufacturers themselves are the ones that sign the truthful and accuracy 

statement, but oftentimes my clients have a hard time understanding what they 

comply with and how they complied with a standard. And they really rely on 

the test labs for that information -- which puts them sort of in an awkward 

situation when they’re putting together the DOC.
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So do you have any ideas of how to best go about that?

Scott Colburn: (Allison), first thank you. Yes, we are all very happy with deletion of Form 

3654!

But to your question about how can we improve an accurate and appropriate 

the Declaration of Conformity especially when you’re working with testing 

laboratories that may not even be within the manufacturer’s organization but a 

third party organization and how can we improve that. There’s a couple ways 

now that I see natural improvements. 

One is that under a laboratory’s accreditation and if they’re being accredited 

under ISO/IEC 17025, the 2017 version of that does permit under the 

accreditation for them to be able to either establish or work with how a 

Declaration Conformity may be able to more accurately reflect how a device 

was tested. 

Secondly, and as I mentioned earlier, we have a new pilot program we are just 

at the very beginning stages of developing and over the course of the next few

months and future you will see more information on the Accreditation Scheme 

for Conformity Assessment Pilot Program that FDA is working on. 

And one of the objectives is to actually work with accreditation bodies and

accredited testing labs who have contracts from manufacturers to certain 

standards that we recognize. And how can we improve the genesis of how the 

appropriate use of standards can apply and receive better Declarations of 

Conformity, supplemental test reports, et cetera and where can we improve 

those areas.
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So I think we will see in natural order (of improvement) through both the 

evolution of the new standards in the ISO 17000 series as well as what we’re 

hoping to receive from the Accreditation Scheme for Conformity Assessment 

or ASCA pilot program, the opportunities for us to help engage and provide 

the regulatory science perspective as well as opening up those areas of 

communication where previously we never really discussed or worked with 

testing laboratories or even accreditation bodies on those topics. 

And hopefully that will help stakeholders -- especially some of the small 

business manufacturers who may not have a long history of developing those 

types of documents. 

Coordinator: Thank you. Our next question is from (Anash). (Anash) your line is open. 

Please check your mute feature 

(Anash): Hi, Scott. My question is about the reference made in the guidance document 

that the use of this guidance is not limited to the abbreviated 510(k) but it can 

also be used for other 510(k). 

So when we list this -- this is a standard form 3514 -- do we also have to 

provide DOCs for the traditional and special 510(k)? 

Scott Colburn: Thank you, (Anash). That’s an interesting perspective on that area. So the 

reason why that statement was in there, believe it or not there are certain areas 

where people feel Declaration of Conformity would only apply to an 

abbreviated 510(k). And that is definitely not a fact. A Declaration of 

Conformity can apply to any type of premarket submission as well as many 

people have Declarations of Conformity in their own files for products that are 

not going through a premarket review process. 
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So yes, that statement was there to just try to make sure and help improve and 

increase the amount of recognized consensus standards that we see. We did an 

analysis to try to understand how standards were being used a few years back 

and we saw that over a third of standards that were cited in 510(k)s that were 

cleared were not cited towards the Declaration of Conformity at all when in 

fact they could have been and potentially lessened the amount of information 

or amount of review that may be required to help assess the appropriate use of 

that standard. 

So the message that the guidance was trying to improve is that the appropriate 

use of standards through a Declaration of Conformity can be to any premarket 

submission as appropriate. It isn’t limited to any one particular type of 

submission. 

Coordinator: And as a reminder to ask a question please press star 1. And our next question 

is from (Thomas).

(Thomas): Yes, thank you for taking my question. In one of your slides you emphasized 

Conformity versus compliance. Can you give a little bit more explanation 

what’s the difference between compliance and conformance? 

Scott Colburn: And I can’t remember exactly what slide that was. But I will speak to that. 

So a Declaration of Conformity is an official attestation that a device is in 

conformance with that standard. Conformity and conformance is a legal 

attestation that demonstrated you have tested the product prior to submission. 

(Thomas) I just want to make sure. You talked about compliance was the 

second aspect?
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(Thomas): Yes. 

Scott Colburn: Compliance. So, we do receive from time to time where someone will say 

well, we are in compliance with that standard. And compliance is not an 

official term that brings us into understanding if you actually did a full 

attestation of conformance to that. 

And we receive that from time to time. That would fit into an area where you 

might say yes, we are in compliance with the standard but maybe we made the 

following adjustments or we used it as our guide, so to speak, but it wasn’t 

necessarily conformed to as published or as recognized to support a 

Declaration of Conformity. 

We want to make sure that when people are submitting the Declaration of 

Conformity that they are making that attestation of conformance under the 

ISO/IEC 17050-1 & -2 series. 

(Thomas): Thank you. 

Coordinator: Thank you. Our next question is from (Amy Panzic).

(Amy Panzic): Hi. I just was wondering if what FDA’s current thinking was on when 

submitting like a 510(k) with the intent to declare a standard rather than 

submitting with conformance to the standard.

Scott Colburn: And (Amy) just real quick are you kind of referring to the area where we 

discussed about promissory statements or promissory notes versus a 

Declaration of Conformity?
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(Amy Panzic): Yes. So traditionally maybe we would say prior to commercial distribution we 

would make sure that we’ve tested and we comply 100% to you know, 601-1-

2 rather than in a submission stating we intend to declare compliant to the 

standard without submitting like actual testing. 

Scott Colburn: Thank you, (Amy). Yes, so I just wanted to make sure I was clear on it. So ye 

that is the difference between submitting a Declaration of Conformity and a 

promissory statement that in effect says what you alluded to -- that you’re 

indicating that you promise you will be in conformance to the standard prior 

to market and are making a promise that you will meet the criteria as outlined 

in the recognized standard. 

This is an area where you saw a shift from the draft guidance to the final 

guidance here. And the first thing -- and again going on the same theme --

make sure that you are speaking with your review team to understand that is 

this particular standard or standards that you’re looking to take this approach 

to satisfy the ability for you to appropriately provide the amount of 

information through the use of that promissory statement to indicate that you 

can still get through the regulatory pathway where a determination of 

substantial equivalent or approval can be made. 

Not all standards are be appropriate obviously for a promissory statement. In 

fact, I would probably even tee it up enough and say most standards may not 

be appropriate. But there are standards that, based upon the design, may 

require that the product be placed into its final installation area, whether it be 

in a hospital setting or maybe there’s real long term testing for certain types of 

shelf life or others, that a promissory statement may be appropriate. But again, 

I would recommend unless you have some sort of historical reference from 

how you’ve done that in the past to connect with your review team just to 

make sure that that would be appropriate for you when you’re submitting. 
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(Amy Panzic): All right. Thank you.

Irene Aihie: We’ll take our next question. 

Scott Colburn: For (Annie)? (Annie) I can’t hear you. You may need to unmute. 

(Annie): Hi. I have a question regarding the applicability of the guidance for the use of 

IDE devices. So let’s say there’s a device used in a clinical study where it 

complies to a 60601 third edition. And the subsequent 3.1 edition comes up. 

So is it required that any ID devices used following the division of this 

standard needs to comply to 3.1 or this is a similar rule similar to 

(unintelligible) marketed device apply for the IDE devices as well? 

Scott Colburn: (Annie) I’m not too sure if I caught that entire question. Can you repeat it one 

more time? I apologize. 

(Annie): Sure. So I had a question regarding the applicability of the standard of the 

guidance for the IDE devices. 

Scott Colburn: Okay.

(Annie): So if there’s a device that is being subject to the clinical trial and let’s say 

complies to 60601 third edition. And then when a 3.1 edition revision comes 

up, is it required that the IDE devices used in the IDE subsequent to the 

implementation date conform to the 3.1 edition? Or does a similar rule like 

they have mentioned after review appearance or an approval of a device once 

it’s legally marketed it’s not necessary to go back and update the device file to 

comply with the portion of the standard. 
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Scott Colburn: Yes. So this kind of falls into the two different areas of answering that 

question. One will be the theme that you received is to make sure that you 

would communicate throughout the development of when you’re going from 

an IDE and maybe into the next stage of what the submission may be, whether 

it’s a 510(k) or a (PMA) type device to discuss a newer standard being 

recognized. Will the use of the standard as outlined as we’ve done through the 

IDE still apply for the appropriate data to support the later submission? 

The other part of it too though is you have to also take into account as a 

manufacturer what is your responsibility and your quality system and how you 

should be looking at the newer standards and how that applies. 

In the end again going back and discussing this with the review team is always 

the best decision first because you do need to take into account -- and the 

beauty of doing things though the IDE and with that interactive approach with 

the agency is that you are probably more aware of current issues that are 

usually addressed in newer versions of standards. And while you may be 

addressing those areas in your submission, if that’s the case you may not 

necessarily need to use the newer version of a standard because you are 

addressing those in other sections of your document. 

However, if you are not addressing any of those newer areas where there is a 

delta between the newer version and the older version that’s not discussed, the 

agency may put an additional information request for you to see how did you 

address those areas that are in the newer standard but not addressed in 

previous areas. 

Again, it goes back to communication and working with the review team as 

the primary way to address that. 
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Coordinator: Thank you. Our next question is from (Christina).

(Christina): Hi. Thank you very much for taking my question. My question is regarding 

the standard (IEC)62304 that is the list of harmonized standards. 

There are currently two versions -- 2006 and 2015. Both versions have 

differences in the way modules are classified from the point of view of 

criticality. The other way the premarket submission guidance suggest a way of 

classifying modules according to the version 62304 2006 not with respect to 

2015. 

My question is if the manufacturer decides to choose conformance with 2015, 

what will be the expectations from the FDA when receiving and reviewing the 

submission of the (BMA) because the level of documentation for the modules 

is different. 

Scott Colburn: Okay, (Christina). First I’ll have to put out there that you asked the poor 

nurse a software question, right - 62304. But I’ll try to just take this from a 

very broad perspective. 

If I understood the question correctly, we have an older guidance that 

discusses the use of an older standard. And from what I’m looking at, the 

standard itself may even call out the date of an older standard. But there’s a 

newer version out there. I don’t have my database in front of me but let’s 

assume that we recognize the newer version of that standard. How does that 

apply when there’s a guidance based upon the older version?

I’m going to again stay to always communicating with the review team may 

be appropriate to see where the structure of the new standard may be different. 

The guidance document usually outlines the general things that the agency is 
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thinking about at that point in time. And if the newer standard has been 

recognized, the agency is also communicating that they feel that the use of 

that standard would also be appropriate. 

This would be an area though that I would say you would need to probably 

speak with the subject matter experts or the contacts within that specific 

guidance document to be able to get a more appropriate answer. 

Coordinator: Thank you. Our next question is from (Sue Heblin).

(Sue Heblin): Hi. Thank you. We are in the process of working on a traditional 510(k), And 

I was curious when you have specific consensus standards associated with the 

product code that don’t seem appropriate for you device yet there are others 

that are like the 62304 and 62366 and 60601. So those are the standards that 

we’re following for testing. And this probably doesn’t matter because I think 

we are submitting all the test reports.

But I was just curious is it an expectation that you address those other 

standards that are not appropriate for your device that are associated with that 

product code? Or are manufacturers typically just silent on that and address 

the ones that are appropriate? 

Scott Colburn: Well (Sue) yes, I can see where that might be a complicated question. So the 

recognition database does try to identify and I’ll call it -- examples of product 

codes that may be suitable for the product area standards for the products that 

have product standards. Areas like (IEC)62304, and all the horizontal 

standards aren’t assigned product codes because in many cases they would be 

applicable to hundreds if not thousands of product codes. 

(Sue Heblin): Right. 
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Scott Colburn: Based upon their horizontal aspect. And so we really only try to tie in 

examples of product codes to try to bring that database into our database 

which then helps also sort what types of standards are available to a 

manufacturer to consider if you’re unable to search for it appropriately in our 

database. Maybe it pops up when you’re looking at a product code in your 

database. 

Is it a complete and always updated system? No because product codes are 

continuously being updated. And we don’t always update the recognition 

database to that effect. That is an area of improvement that we are interested 

in trying to advance. But in the end, it’s really the manufacturers making the 

decision of which standards. It’s a voluntary system so which standards do 

you feel are appropriate to help you make that case, make that story to help 

demonstrate how you are achieving what your intended use is or what you’re 

trying to show for safety and effectiveness claims. 

So really it’s more of an assistive tool than a directive tool. It’s really there for 

you to try to be helpful than more directive in that respect. 

Coordinator: Thank you. Our next question is from (Margaret). 

(Margaret): Yes hi Scott. I have a question related to pre-submission. Do people really 

need to put in the recognized standards when they’re going to be used in a 

510(k) in a pre-sub? Or can we either use a promissory note or state that these 

standards will be used in the 510(k)? 

Scott Colburn: Yes, (Margaret) I’ll admit I think, a pre-sub obviously is something different 

than a final submission. I think the information that is placed in you might not 

have conducted testing on certain areas. So showing what standards you 
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would be using. I don’t even know if a promissory statement would be 

necessary for that effect at that statement but maybe indicating these are the 

standards or the test methods or the things that we’re looking to utilize would 

be more appropriate. 

This was an interesting question that maybe even bringing it to DICE or to the 

review team of course is there. But the pre-sub is obviously not an active 

review at that time. And so the expectation of utilizing full blown 

Declarations of Conformity or promissory statements wouldn’t have that same 

weight, so to speak, as you would have with an active review under a 510(k) 

or a PMA submission. 

(Margaret): I see. Which is (unintelligible) I mean for... 

Scott Colburn: I’m sorry (Margaret). You clipped out for a second. Can you repeat?

(Margaret): Yes, sure. Does that mean that in a pre-sub it’s not necessary on the form to 

list the recognized standards?

Scott Colburn: No, I wouldn’t say it’s a requirement in a pre-sub, (Margaret). But I state that, 

any time you’re trying to share the information that you’re using to the agency 

and if standards do apply, that you could have that somewhere in the 

information contained. But again, having what you’re trying to get from the 

pre-sub process would look at what standards are you planning to use and is 

that approach acceptable. 

Again, I think obviously asking the question to the review team too would be 

more beneficial. I admit that is not my highest area of competence and 

understanding that process for this specific area. But I do see where it does 

apply because listing the types of standards you’re looking at doing is an 
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important tool since virtually every submission does list I think we have an 

average of seven or more standards in any particular submission that we see 

coming in. 

So the discussion of how standards apply appropriately is obviously 

something of interest I think you would want to indicate in your pre-sub. 

Coordinator: Thank you. And I am showing no further questions. I’d now like to turn the 

call back to Irene for closing remarks. 

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

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

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

Friday November 2. 

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 

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immediately following the conclusion of today’s live webinar. 

Again, thank you for participating and this concludes today’s webinar. 

Coordinator: Thank you. This does conclude today’s conference. You may disconnect at 

this time. 

END