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 organization. Specific changes included:
- adding a 60-day timeframe for FDA’s response to recognition requests,
- directing the FDA to issue a response in writing, and,
- directing the FDA to publish on its website its rationale for recognition of all, part, or none of a standard.
Submitting a Request for Recognition
A request for recognition of a standard should contain, at a minimum, the following information:
- Name and electronic or mailing address of the requestor,
- Title of the standard,
- Any reference number and date,
- Proposed list of devices for which a declaration of conformity should routinely apply,
- Basis for supporting such recognition request, e.g., including the scientific, technical, regulatory, or other basis for such request, etc., and,
- A brief identification of the testing or performance or other characteristics of the device(s) or process(es) that would be addressed by a declaration of conformity.
Submit one paper copy by mail to the CDRH Standards Program at the address below or electronically at: CDRHStandardsStaff@fda.hhs.gov.
CDRH Standards Program
Office of the Center Director
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Not later than 60 calendar days after the CDRH Standards Program has received a request for recognition, the FDA will make a determination to recognize all, part, or none of the standard that is subject of the request and issue a statement to the requester of its rationale for that determination. The statement will include the scientific, technical, regulatory, or other basis for the determination.
The FDA will publish its determination in the Federal Register. A list of these Federal Register notices can be found on our Federal Register page located at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.