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See Related InformationOpportunity to Recommend 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

Updated May 29, 2008

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