Recommending Standards for CDRH Recognition

Individuals who wish to propose standards to the CDRH for recognition under Section 514(c) of the Food, Drug, and Cosmetic Act should, at a minimum, submit the following information:

1. title of the standard;
2. any reference number and date;
3. name and address of the nationally or internationally recognized standards development organization;
4. a proposed list of devices for which a declaration of conformity should routinely apply; and
5. a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity.

Recommendations to consider standards for the list of recognized standards, may be submitted at any time to:

Carol L. Herman, Director
Standards Management Staff
Office of Science and Engineering Laboratories
Center for Devices and Radiological Health
7520 Standish Place, HFZ-84
Rockville, MD 20855

Telephone: 240-276-8715
Email: carol.herman@fda.hhs.gov

Guidance Pertaining to the FDA Modernization Act