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CDRH Learn - How to Use Consensus Standards in Premarket Submissions

Slide 1 

Hello, my name is Scott Colburn, and I am the director of the Standards and Conformity Assessment 

Program, or S-CAP, at CDRH. Welcome to this CDRH Learn module. In today’s presentation, we’ll review 

how to effectively and appropriately use consensus standards in premarket submissions. For the 

purposes of this module, I will use the terms standards and consensus standards interchangeably. 

Before we get into how to use standards, it’s helpful to remember why we should use them. Using 

consensus standards in premarket submissions offers significant benefits.

Slide 2 

First, the use of standards enhances regulatory science and promotes a least burdensome approach to 

device oversight. Standards introduce efficiencies into the pre-market review process by setting clear 

expectations for conformity assessment and test reporting. Using declarations of conformity with FDArecognized standards can increase predictability, streamline premarket review, provide clearer 

regulatory expectations, and facilitate market entry. And using international consensus standards 

reduces burdens on device companies by harmonizing expectations across international jurisdictions.

Second, consensus standards promote quality. Crowd-sourcing standards leads to clearer performance 

expectations. Relying upon input from around the world ensures that we tap into expertise that no one 

manufacturer or regulator or clinician will have access to. Robust standards development and standards 

revision processes yield standards that can keep up with technological advances!

Finally, using standards helps ensure that innovative, safe and effective devices are available: by 

optimizing ‘bench to bedside’ time, we get life-saving products to the patients we all serve. The 

appropriate use of consensus standards encourages innovation and competition among product 

developers by providing a level playing field. With everyone playing by the same rules, or in this case, 

standards, more and better devices can be introduced into the market!

Slide 3

What do we hope to accomplish today? We have four objectives: First, we’ll explain how to use 

standards in device submissions, reviewing submission expectations in detail. Then, we’ll describe how 

declarations of conformity can improve the quality of submissions and their positive impact on device 

review, because much of the benefit of using standards is predicated upon the appropriate use of 

declarations of conformity! We’ll also identify when supplemental documentation is needed and what 

that documentation should include. And finally, we’ll discuss Helpful Tips for using standards and 

declarations of conformity in medical device submissions.

Slide 4 

Now that I have introduced consensus standards and their important role in the medical device 

community, I want to focus on how to use consensus standards in a device premarket submission.

Slide 5

Consensus standards play a key role the pre-market review space. But before we talk more about the 

specifics, it’s important to emphasize the key point that the use of consensus standards is voluntary. 

FDA strongly recommends using consensus standards, for all the reasons we just talked about. But their 

use by a manufacturer is voluntary, unless ‘incorporated by reference’ into a regulation. 
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If you, as the manufacturer, wish to demonstrate conformity to expectations in other ways, that is your 

prerogative. Just be prepared to justify your approach! Now, back to business: standards may be cited in 

any type of submission. If the standard is recognized by the FDA, the declaration of conformity will 

reduce the need for supplemental documentation, but ‘General Use’ of a standard is also an option. Just 

know that additional documentation will be needed. We’ll talk more about the General Use of standards 

in a moment.

Slide 6 

Form FDA 3514 Cover Sheet is an important resource for your device submission. Note that this form 

would be used in addition to any submission cover letter your company might also include in 

submissions. Use of Form 3514 Cover Sheet is voluntary, but we recommend it as it helps ensure you 

have correctly cited standards in your paperwork. I’ve included a link to it on this slide. Section J of Form 

3514 is where you’ll go to include your standards’ citations. See the section outlined in blue? This is an 

‘examples’ section. It is included to provide some direction on what will go in the form. There are 5 

columns in the first box in this section and I’m going to discuss each of these columns in more detail. But 

before I do, note that the section below outlined in bright red is where you will actually enter your 

submission’s standards information. 

Slide 7 

See this button in the bottom right of the Utilization Section, that I’ve highlighted in red? You’ll click on 

that button for every standard you wish to add to Form 3514.

Slide 8 

I’m going to go from left to right and point out the elements that you will need to enter. The first column 

on the left highlighted by the dark red box is for the standard’s Recognition Number: enter the FDA 

recognition number – which is found in the Consensus Standards Recognition database at the link 

provided at the bottom of this slide. This database has tons of valuable information and if you haven’t 

spent time with it yet, please do, as it will really help you as you ‘put standards to work.’ If the standard 

is not recognized, which means you are citing it under ‘General Use,’ write NR in the Utilization section.

Slide 9 

The next column to the right, highlighted in blue, is where you indicate whether you are using a 

declaration of conformity or if you are submitting under ‘General Use.’ Select ‘Declaration of 

Conformity’ if you are including a “Declaration of Conformity to a Recognized Standard” statement. For 

all other uses, select ‘General Use.’ In both cases you should note if you have made deviations from the 

expectations of the recognized or non-recognized standard.

Slide 10 

Moving on, the column in the green box is where you state the Standards Development Organization 

(SDO), the standard’s Designation Number (including the year), and the title of the standard you are 

citing.

Slide 11 

The last column highlighted in gold tells us where the standard is applied in your submission. Pointing 

the FDA reviewer to the page numbers helps save a lot of time.
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Slide 12

Now let’s take a deeper dive into the declaration of conformity, or DOC.

Slide 13 

So, what is a declaration of conformity? A declaration of conformity 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. It confirms to the FDA that all normative requirements have been met, that tests have 

been conducted, and that those tests were performed on a finished device. If the submitter declares 

conformity to an FDA-recognized standard, a declaration of conformity must be included in the 

premarket submission. Using a declaration of conformity may reduce the amount of supplemental 

information needed in a submission. We’ll talk more about what we mean by ‘supplemental 

information’ in just a bit.

Slide 14 

We at FDA want to encourage the use of declarations of conformity, so we wrote a guidance. Published 

in 2018, the Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 

Devices lays out what a declaration of conformity should contain. 

Since the Standards and Conformity Assessment Program also prioritizes a reliance upon international 

consensus standards whenever possible, this guidance builds upon ISO/IEC 17050-1, cited at the 

bottom. The Appropriate Use guidance stipulates the following elements: the sponsor’s contact 

information, the device’s identifying information, the actual statement of conformity and all the 

standards being cited - be sure to include their FDA recognition numbers.

Slide 15 

The other elements of a declaration of conformity are the date and place where the declaration of 

conformity was issued, the signature of the responsible party, any limitations on the declaration of 

conformity’s validity, and finally, any supplemental documentation supporting the declaration of 

conformity. Let’s take a look at an example of a declaration of conformity.

Slide 16 

This is an example of a declaration of conformity. Note that this is not an FDA form. It’s an example 

declaration of conformity adapted from the Accreditation Scheme for Conformity Assessment Pilot. But 

it contains everything FDA will need to efficiently evaluate your conformance. You may certainly use 

different formats but be sure to share all of the information we’re getting ready to discuss. 

Let’s go through each of the three following sections so that you can be comfortable using a declaration 

of conformity. We’ll discuss the responsible party and the product or device identification, then the 

actual statement of conformity and finally the limitations of validity section of a declaration of 

conformity, as well as the signature element.

Slide 17 

Before I dive into the specific information needed, I urge you to review the Appropriate Use of Voluntary 

Consensus Standards guidance for an excellent resource, along with standards ISO/IEC 17050 parts 1 

and 2. So here in the first section, you can see where to enter the responsible party’s information –

name and address - and the device identifiers. This includes both manufacturer-specific information like 

model numbers as well as the FDA procode.
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Slide 18 

The actual statement of conformity, the attestation, goes in this section. It looks like a lot of 

information, but it’s very straightforward. The statement should include these details for each standard 

cited. At the very top, you can see the actual statement of conformity: don’t forget to make that 

statement! Next, enter the standard’s title and FDA recognition number. Then you’ll enter whether your 

submission features ‘options.’ In other words, if a standard provides alternative test methods or 

conditions and you took advantage of that, you’d note that here. Next is the test lab information, the 

date testing was conducted and an indication of whether you are including supplemental 

documentation – we’ll talk more about supplemental documentation shortly.

Slide 19 

The last section is where you will list any ‘limitations on the validity’ of the declaration of conformity. 

What we mean by limitations on validity is this: we recognize that some standards are very complex and 

that testing outcomes do not always fit nicely into a box. This is where you will explain and provide your 

rationale for such a limitation on validity. And finally, you should provide the name and signature of the 

responsible party. 

Slide 20 

Before we turn to a discussion of when and what types of supplemental documentation may be needed, 

recall that standards are voluntary. That means you may also use other, non-recognized consensus 

standards. However, since declarations of conformity are not included in these ‘General Use’ cases, 

complete test reports should be included as part of your submission. These reports will need review by 

FDA, adding time to the review process. For more complex standards, like product-specific standards, 

modifications might sometimes be needed, which would call for complete test reports for that aspect of 

the standard, though a declaration of conformity could still be used for the rest of the standard. 

For a lot more detailed information about the General Use of a standard, visit that guidance I just 

mentioned: the Appropriate Use of Voluntary Consensus Standards. And remember you can always ask 

the FDA review team for advice! 

Slide 21 

Our shared goal is that standards should – whenever possible – have clear test methods and acceptance 

criteria built into them. This makes everyone’s lives a lot easier – and makes standards ‘regulatoryready.’ And that is one reason FDA prioritizes having regulators at the standards development table, so 

we can remind standards developers of that! But we don’t live in a perfect world, so I’d like to share 

with you how to determine if your declaration of conformity needs to be accompanied by supplemental 

documentation, and what form that documentation should take.

Slide 22 

This table is taken from the Appropriate Use guidance I keep talking about. It summarizes when and 

what sorts of supplemental documentation are needed. Let’s walk through the different scenarios 

outlined in the table.

Slide 23 

The first line of the table points out that standards specifying design requirements, even if they have 

acceptance criteria or test methods, do not need to be accompanied by supplemental documentation. 
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Slide 24 

As you can see in the red box, sometimes a standard has a test method but not acceptance criteria. In 

those cases, the complete test report is not needed, but your supplemental documentation should 

reference the criteria you tested to. 

Slide 25 

Below that line outlined in blue is the opposite case: the standard may feature acceptance criteria, but 

not specify a test method. As in the previous case, a complete test report is not needed, but you should 

submit supplemental documentation about the testing methods you chose and why you chose them. 

Slide 26 

As you can see in the green box, when both test methods AND acceptance criteria are called out in the 

standard, and you use and apply them as written, FDA doesn’t need any supplemental documentation. 

This is really the best-case scenario, as it can save you and the FDA time. One caveat: sometimes 

standards offer choices in test methods. When that is the case, you should let FDA know what you chose 

and why with your supplemental documentation. 

Slide 27 

The final line in the table, outlined in yellow, is our worst-case scenario: neither test methods nor 

acceptance criteria are included in the standard. For those standards, you’d need to submit the 

complete test reports. 

Slide 28 

So you can see that it’s pretty clear when supplemental documentation will be needed: when there are 

not methods or acceptance criteria called out, and when you have applied deviations to the standard. In 

these cases, FDA should see complete test reports. And if you decide to cite a non-recognized standard 

under ‘General Use’ of a standard even MORE documentation will be needed. Let’s take a look at a realworld example next: an ANSI/AAMI human factors standard.

Slide 29 

ANSI/AAMI HE75-2009 is a human factors standard. In this case, FDA recognizes most, but not all of the 

standard. This is known as a partial recognition. We do not recognize Section 9: Usability testing. That is 

because that section conflicts with Appendix A of the FDA guidance entitled Applying Human Factors 

and Usability Engineering to Medical Devices. In this example, complete test reports will be needed for 

usability testing, which is further outlined in the FDA guidance. 

Slide 30 

To emphasize: supplemental documentation is NOT needed when citing a design standard. Nor is it 

needed when test methods and acceptance criteria are specified. For example, ISO 17665-1, a 

sterilization standard, has both so we can rely on declarations of conformity alone – no supplemental 

documentation should be needed!

Slide 31 

Let’s go over some helpful hints to ensure you are ‘putting standards to work’ appropriately.

Slide 32 

We’ve told you a lot of things TO do, what about what NOT to do? Well first of all, take care not to use 

standards inappropriately. Don’t use standards that don’t apply to your device, and don’t forget to 
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check the extent of recognition as identified in the Recognized Standards database. If a standard or a 

section of a standard is NOT recognized, you may not submit a declaration of conformity to it.

Second, avoid inappropriate uses of declarations of conformity. Don’t send a declaration of conformity 

citing a non-recognized standard, or one that is an old version no longer recognized by FDA. Be careful 

with deviations. As I mentioned earlier, some standards have permissible modifications built in. You are 

allowed to choose a test method for example, and then you’d share with us why you chose that method. 

However, if you make a deviation to a method or acceptance criteria that is NOT called out in the 

standard, you should send supplemental documentation that clearly tells us what you did and why you 

did it. And in all cases in which supplemental documentation is called for, it goes without saying – please 

don’t forget to include it in your submission.

Slide 33 

Next, don’t fall into the trap of thinking that using a recognized standard satisfies ALL questions in a 

premarket submission. Don’t forget to check relevant regulations and FDA guidances for what is needed. 

And finally, FDA Form 3654 expired in 2018 – please don’t use it!

Slide 34 

We’ve covered a lot of ground here today, and I thank you for your attention. We discussed how to use 

standards in device submissions, and how declarations of conformity can make regulatory review more 

efficient. We specified when supplemental documentation is needed, and what form it should take 

based upon various scenarios.

Finally, we shared some more general tips on how to successfully use standards and declarations of 

conformity.

Slides 35 

Here are some excellent web sites I encourage you to review. These include the Standards and 

Conformity Assessment Program’s web page, the Recognized Consensus Standards database, Device 

Advice resources and a CDRH Learn module with more information about standards and device review. 

Slide 36 

We always encourage you to become familiar with FDA guidances. Here are two that are relevant to 

today’s module: the Appropriate Use of Voluntary Consensus Standards we’ve mentioned before and 

the Recognition and Withdrawal of Voluntary Consensus Standards guidance. Please don’t hesitate to 

write to us at CDRHStandardsStaff@fda.hhs.gov with any questions or feedback. We welcome hearing 

from you.

Slide 37 

As always, we encourage you to refer to CDRH Learn and Device Advice for additional regulatory 

education. You may also contact D – I – C - E directly with any general regulatory questions you may 

have. We are happy to assist you by phone or email. Please refer to the information provided on this 

slide for our hours of operation.

Slide 38 

I leave you with this call to action: Hopefully we have convinced you to ‘put standards to work’ by using 

FDA-recognized consensus standards in your device submissions. And while their use is completely 

voluntary, if you submit a declaration of conformity, it can save time. Be sure that your documentation 
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is complete – knowing when and what to submit can help you avoid delays in your device’s review. We’d 

also like to use this opportunity to encourage you to get involved in standards development. Effective 

use of standards doesn’t start and end with citing them in device submissions. Helping standards 

development organizations write better, ‘regulatory-ready’ standards that are fit for use in device 

review is an important priority, one which we hope you share with us. Thank you for watching today! 

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