CDRH Standards Recognition Process

1

with Scott Colburn

Slide 1

Hello, I am Scott Colburn, the Director of the Standards Management Staff in the Center 

for Devices and Radiological Health or CDRH. In this CDRH Learn Module, I will 

discuss how CDRH evaluates candidate standards for recognition and how you may 

request recognition of a standard.

Slide 2

Let's review the learning objectives of this module. You'll understand how CDRH 

assesses and recognizes standards. You'll be able to identify the different types of 

recognition and find Federal Register notices that list the recognized standards. You'll 

understand how the different standards organizations maintain standards, and you'll 

learn how to request the recognition of a standard.

Slide 3

To begin this module, I would like to state our mission. The CDRH Standards Program 

was established as a result of the Food and Drug Administration Modernization Act 

(FDAMA) of 1997. The program contributes to the Center's mission of protecting and 

promoting public health through the development and recognition of voluntary 

consensus standards that serve to establish safe and effective medical devices, 

radiation-emitting products and emerging technologies.

Slide 4

Our vision is that CDRH stakeholders have access to high-quality, safe, and effective 

medical devices of public health importance first in the world through timely 

development and recognition of voluntary consensus standards. The CDRH Standards 

Program is the world's leader in standards implementation and utilization for medical 

device innovation and manufacturing, and radiation-emitting product safety. Medical 

Device manufacturers, consumers, patients, and providers have access to voluntary 

consensus standards for medical devices and use this information to protect and 

promote the public health.

Slide 5

The Standards Management Staff, or SMS, is located within the Office of the Center 

Director in CDRH and has a number of functions and responsibilities.

We guide the standards recognition process, set priorities for standards participation, 

manage standards travel and travel budget priorities, oversee the Center consensus 

process with regards to review of committee drafts and ballots, administer and maintain 

FDA liaison representatives to Standards Development Organizations, or SDOs, and 

committees and working groups. We maintain membership to SDOs, maintain 

agreements for access to published standards, and manage Federal Register 

publications.
Slide 6

2

CDRH manages the standards consensus process through the establishment of 

specialty task groups. This slide lists the CDRH specialty task groups. The specialties 

are very similar to the CDRH Advisory Committees or panels; however, they also 

include cross-cutting specialties such as biocompatibility, quality systems, risk 

management, electrical safety, materials, software and informatics, and sterility to name 

a few.

Slide 7

Each Specialty Task Group or STG is comprised of at least one representative from the 

different Offices within CDRH. In addition, STGs may include staff from other FDA 

organizations where appropriate, such as the Center for Biologics Evaluation and 

Research, or CBER, if these other organizations bear regulatory responsibility for 

devices addressed by standards under the purview of the STG. The STGs, under the 

general direction of the SMS, are responsible for coordinating all CDRH consensus 

standards activities within their assigned technical area. This responsibility includes 

interacting with the independent Standards Development Organizations, or SDOs, 

related to their assigned device area and communicating the status of standards 

activities to their respective office managers.

Slide 8

The STG has a number of duties. The STG identifies existing and needed standards 

within its technical area and prioritizes current and potential standards development 

activities using an objective criteria that evaluates its utility to CDRH programs. The 

STGs coordinates the assessment of whether a standard can be used to meet a 

particular premarket or other statutory requirement. 

It recommends the recognition of standards through publication in the Federal Register. 

The STG recommends liaisons, alternates, and technical experts and develops the 

Supplemental Information Sheet, or SIS, for a recognized standard. 

You can access a current list of STGs at the CDRH Standards Program page. The 

STGs report to the Standards Management Staff Director.

Slide 9

CDRH recognizes standards. The term "recognize" or "recognition" is defined in 

Section 514(c) of the Food, Drug, and Cosmetic Act, and refers to FDA's identification of 

standards as appropriate for manufacturers of medical devices to declare conformance 

or to use the standard in a submission or other aspect to satisfy a requirement.

Slide 10

The SMS is responsible for coordinating the Center's efforts to recognize standards. It 

does this by collecting information on newly published standards, searching the internet 

and standards developer's publications, and compiling this into a list of candidate 

standards for recognition. 

The SMS looks specifically for title changes, newly published amendments and 

corrigenda, and new editions of standards that have been published. In addition, the 
SMS searches for standards that are no longer in publication that would be candidates 

for withdrawal.

Sllide 11

3

After the SMS completes the tasks described in the prior slide, the list of candidate 

standards is moved to the STG. If a standard requires a particular expertise that is not 

available within the STG, then a Project Team is formed. 

The STG or Project will then recommend one of the following decisions: 

1. recognition of the complete standard, 

2. recognition of the standard in part, identifying the specific parts of the standard that 

are not appropriate; or

3. non-recognition of the complete standard. The standard may also be deferred for 

future assessment.

If the Project Team recommends all or part of a standard for recognition, it must identify 

examples of devices to which the standard would ordinarily apply. The STG or Project 

Team will also identify whether there are any applicable guidances and any areas of 

agreement or disagreement between the standard and such guidances.

Slide 12

After the STG has made a decision, the SMS will compile this information into a Federal 

Register notice and announce the list of recognitions as outlined in Section 514 (c) of 

the regulations on standards. This is done twice a year. The Federal Register 

announcement is directly in effect for immediate availability for industry, stakeholders, 

and regulators to use in their submissions or processes.

Slide 13

The SMS places links to each published Federal Register on the FDA website as noted 

on this screenshot. The link to this website is also included on this slide. 

Slide 14

The SMS updates the FDA Recognized Standards Database that is available on the 

FDA website. This slide shows a screenshot of the standards database search wizard 

as well as the link to the website. For every recognized standard, we also generate the 

Supplemental Information Sheet that describes the Agency's thinking on each standard. 

You can get more information about this process by viewing the companion CDRH 

Learn module titled Standards Resources and Premarket Use. 

Slide 15

Standards are maintained by the standards developing organization on a fairly 

predictable schedule. Typically, a newly published standard will come up for renewal or 

revision 3 years after its first publication. After that, standards are reviewed for either 
revision or reaffirmation, which is renewal without any changes, every 5 years. Within 

the US, each ANSI accredited standards developing organization has written policies 

and procedures for how often they maintain the standards they produce. 

Slide 16

4

As noted on this slide, the Center has a guidance and process for requests for 

recognition. 

Slide 17

Any stakeholder may propose a standard be recognized. To make a request, one 

should include this information: the title of the standard, any reference number and date 

for that standard, the name and address of the SDO, a proposed list of devices or 

device types, and a brief discussion of the testing or performance or other 

characteristics that would be addressed by the standard.

Slide 18

If you are interested in submitting a request, follow the link to this slide for the contact 

information to reach us. 

Slide 19

This slide gives a visual of the process or pathway of the steps that the Center takes 

when considering a candidate standard for recognition. I'll touch upon some of the key 

milestones in the process. When a request is received, the SMS Director will transmit 

any outside recommendations for recognition to the appropriate STGs for assessment, 

along with a reasonable timeframe for the STG response. The report of the assessment 

of the STG will be referred back to the SMS Director. If the STG endorses the outside 

recommendation for recognition, they will also include in their report to the SMS Director 

one or more completed supplementary information sheets for the standard proposed for 

recognition. If the STG does not endorse or does not fully endorse the outside 

recommendation for recognition, it will document its rationale for this.

Slide 20

Let's review what we discussed in this module. First, we learned how CDRH assesses 

and recognizes standards. We identified the different types of standards. We learned 

where FDA posts the Federal Register notices of lists of recognized standards. We 

learned how different standards organizations maintain standards. And we learned how 

to request the recognition of a standard. Thank you.

 ####################