1

 CDRH Learn – Standards: Resources and Use in Premarket Submissions

 with Jianchao Zeng

Slide 1

Hello, my name is Jianchao Zeng and I am a Senior Standards Advisor at the CDRH Standards 

Program. In this CDRH Learn module, I will discuss some resources for FDA recognized 

consensus standards and how they are used in premarket submissions to CDRH.

Slide 2

In this module, you'll learn how to find and locate standards in the FDA Recognized Standards 

Database on our website. You'll also find FDA guidance documents specific to the use of 

standards. You'll be able to identify and decipher the full title of a standard. You'll be able to 

locate Supplementary Information useful in understanding how FDA recognizes a standard. 

We'll discuss the two main ways to use standards via General Use or Declaration of Conformity. 

And finally, you'll understand the elements of a declaration of conformity and how it's used.

Slide 3

To understand which and how standards can be used in premarket submissions to CDRH, it's 

important to know that not all standards are equal in terms of their use. Some standards are 

test methods and have pre-specified objective performance criteria, others are guidelines that 

have choices or pathways to follow with regards to testing requirements, and still others are 

practices or have a set of suggested options. Knowing the type of standards product that's 

being used will guide how much information to supply in a submission. 

Slide 4 

FDA maintains a current repository of recognized standards in a database found at the FDA 

website listed on this slide. The database is publicly available and each recognized standard 

contains a Supplementary Information Sheet, or SIS. While not comprehensive, the SIS 

commonly notes the device type as listed by its product code that is addressed by the standard. 

The standards contained in this database are recognized by FDA, either completely or in part, 

and stakeholders may elect to use them with or without making a declaration of conformity. 

Slide 5

This slide shows a screenshot of the Consensus Standards Database. From here, you can use 

the search wizard to find a specific standard of interest, along with its corresponding 

Supplementary Information. 

Slide 6

The search wizard has a number of fields you can use to help with your search. Not all search 

fields need to be filled out to conduct your search. Search fields include the standards 

organization, standard designation number, standards title or keyword, specialty task group, and 

product codes.

Slide 7 

This slide shows an example of a search. Here we selected "Cardiovascular" as the "Specialty 

Task Group Area" and then ran the search to total number of standards in this category. If you 

look above the table on the left, you'll see the total number of standards associated with the 

category "cardiovascular." On the right hand side, highlighted in the yellow circle, you can 

change the number of standards presented per page. 
2

This sort can be downloaded for your convenience, however please check back with the 

database as we'll refresh it each time a Federal Register recognition list is published. If you 

click on a standard title, the Supplementary Information Sheet for that standard will appear.

Slide 8 

This slide shows an example of an SIS for a particular cardiovascular standard. In this case, 

this standard pertains to non-invasive blood pressure devices. The standard was published in 

2007 but was most recently recognized on January 30, 2014. As a reminder, the SIS is 

published when FDA recognizes a standard.

Slide 9

The Supplementary Information Sheet is CDRH's determination of how the standard should be 

used in a premarket submission or other Center process. CDRH has built-in latitude to support 

the recognition of a standard even if some aspects conflict with an FDA position and the Center 

does this by recognizing a standard in part. In this way, the Center may communicate that the 

standard may still be useful to the rest of the community even if it is not directly useful in 

premarket review. An example of this would be a practice guideline for how a device would be 

used in hospitals or by medical personnel. 

Slide 10

This slide outlines the type of information included in a Supplementary Information Sheet. The 

SIS includes the Recognition List number, which is the number on the Federal Register Notice 

of Recognition, and the date of the publication of the Federal Register. We also include a 

Recognition number. 

Other details, such as the standards developer, its designation number, and the date the 

standard was published, are also included. The SIS identifies any parallel adoptions, scope and 

rationale for recognition. Also included are the type of standard, extent of recognition, related 

product codes or classification, and any published guidances that refer to the standard. At the 

bottom of the SIS are the FDA technical points of contact and the SDO's address. Finally, if 

applicable, you'll also find a history of recognition which lists related standards that have been 

withdrawn (including earlier editions, corrections, amendments, and superseded standards).

Slide 11

On this slide, we break down the anatomy of the full description of the title of a recognized 

international standard with an example. Starting from the left, underlined in red, we have the 

standards developing organization, which is IEC for this example. IEC is an international 

standards organization, which also means this is an international standard. To the right of the 

SDO, underlined in blue, is the standard's designation number, which is 60601-2-13. The 

edition, underlined in black, and year of publication, underlined in green, are next listed - in this 

example, Edition 3.1 of this standard was published in 2009. And we conclude with the full title 

of the standard, underlined in brown. This is a standard specific to the safety and essential 

performance of anaesthetic systems.

Slide 12

This slide lists an example of a recognized U.S. national standard. The SDO is the Association 

for Advancement of Medical Instrumentation or AAMI, which is a U.S. developer. This standard 

was accredited through the American National Standards Institute, or ANSI. This standard's 

designation number is BP22 and it was originally published in 1994. You'll next see the letter R 

in parentheses, followed by the year 2011. This means that the standard was reaffirmed in 

2011. And finally, we conclude with the title of this standard, which is blood pressure 

transducers.
3

Slide 13

This slide includes an example of a recognized US parallel adoption of an international 

standard. This is done by combining the U.S. standard developer, AAMI, the US accrediting 

body, ANSI, and the international standards developer, ISO. Next listed is the standard's 

designation number, which is 7198. Next are three dates, which are from left to right, the 

original publication of the standard, the date the standard was adopted in parallel, and the most 

recent date the standard was reaffirmed. The description then concludes with the title of the 

standard, which is Cardiovascular Implants, Tubular Vascular Prosthesis.

Slide 14 - Standards Guidances

This slide includes useful links to some standards-related guidances. This is an excellent 

resource to get more information about the standards process. 

Slide 15 - Two Ways to Use a Standard in Submissions

A standard may primarily be used in two ways in a medical device submission: General use or 

Declaration of Conformity. Over the next few slides, we'll go over both ways so you can decide 

which approach is most suitable for your submission.

Slide 16

General use of a consensus standard refers to submissions in which a submitter demonstrates 

conformance to a part of, or an entire consensus standard, but does not submit a Declaration of 

Conformity. This applies to any standard, whether or not it is recognized. In this situation, the 

submitter should discuss how the standard was used by providing a full test report. A submitter 

may apply a general use of a standard to any type of submission. 

Slide 17

The second way to use a standard is with a Declaration of Conformity or DoC. In this case, the 

submitter certifies that its device conforms to all of the applicable requirements of an FDArecognized consensus standard. The submitter may not deviate from the FDA-recognized 

consensus standard. Additionally, a submitter may not submit a DoC if the submitter used a 

consensus standard that has not been recognized by FDA.

Slide 18

Over the next few slides, I'll outline the elements of a declaration of conformity.

First, provide the name, organization and address of the submitter who is responsible for the 

declaration. Then, identify the medical device to which the declaration applies. Third, provide a 

statement of conformity and include, for each standard, the options or choices that were 

selected. Next, provide a list of FDA recognized standards and the corresponding recognition 

number for each.

Slide 19 

Next, list the date, address and signature of the responsible person making the DoC. And 

finally, describe any limitation of the validity of the declaration. For example, a limitation would 

be that the declaration is valid during a certain timeframe. The order of elements shown in 

these slides is not prescriptive. You may also choose to create a Declaration of Conformity 

using the format described in ISO/IEC 17050-1 Conformity assessment - Supplier's Declaration 

of Conformity - Part 1 General requirements.
4

Slide 20 

The purpose of declaring conformance to an FDA-recognized consensus standard is to meet 

certain premarket requirements and reduce the amount of supporting data and information 

submitted to CDRH. Keep in mind, a submitter needs to certify that the device was tested and 

conforms to the FDA-recognized consensus standard. This is not a future promise to meet the 

standard upon further testing.

Slide 21 

In some cases, it's sufficient for a submitter to provide a DoC to support the premarket 

submission. This is because the standard has enough specificity and detail with respect to test 

methods, test specifications, pass/fail criteria, and/or pre-specified testing requirements or 

outcomes, so that CDRH doesn't need to review the full test data to understand how 

conformance was established.

Slide 22 

In some cases, however, a standard will need both a DoC and supporting documentation. 

Examples of these types of standards include guidelines or practices, technical reports or 

technical information reports. The reason is that these types of standards may include options 

within the test methods, or lack details such as pass/fail criteria. As a result, the supporting 

documentation provides this added detailed information. 

The ISO standard cited on this slide can be used to help develop the necessary information. I'll 

go into some detail on this on the next slide. 

Slide 23

In cases where the standard provides an option or a choice, document the selection made and 

the rationale for that choice.

The documentation should describe the test methods. If an option was chosen, or the test 

method was adapted or modified to fit the device, this should be explained. In some cases, you 

may need to modify the device in order to complete the testing described in the standard. This 

would need to be explained.

And finally, was testing conducted on the final finished device? If not, you should explain why 

this was done and why the results are still acceptable.

Slide 24

In a promissory statement, a submitter indicates that testing on the device has not yet been 

completed at the time of the premarket submission. In this case, the submitter promises to 

complete the specified testing prior to marketing. In limited cases, FDA will accept a promissory 

statement. Keep in mind, however, that a promissory statement is not a declaration of 

conformity, because the testing has not yet been completed as required by the DoC.

Slide 25

Let's recap what we reviewed in this module. First, we reviewed how to find FDA-recognized 

standards. We navigated the FDA website to review the specific search features of the 

standards database. We provided links to relevant guidances on standards. 

We also reviewed the anatomy of a standard title using examples of a national, an international 

standard, and a US parallel adoption of an international standard. Finally, we reviewed 

elements of a Declaration of Conformity, and discussed where standards may be used,

including the use of promissory statements.
5

Slide 26

Thank you for your attention to this CDRH Learn Module: Standards -Resources and Use in 

Premarket Submissions. We hope you found this module helpful. We encourage you to use 

other industry education resources we've developed especially for you, as shown on this slide.

Thanks for watching this program and we'll see you next time.

************