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U.S. Department of Health and Human Services

Medical Devices

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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:

Scott A. Colburn, Director
Standards Management Staff
Office of the Center Director
Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO66-3632
Silver Spring, MD 20993-0002

Telephone: 301-796-6287
Email: scott.colburn@fda.hhs.gov

Guidance Pertaining to the FDA Modernization Act

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