Medical Devices

Recommending Standards for CDRH Recognition

Any interested party may request recognition of a standard. As specified in the Federal Register notice dated February 25, 1998 (63 FR 9531), a recommendation for recognition of a standard should, at a minimum, contain 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 recognition, e.g., including the scientific, technical, regulatory, or other basis for such request, etc.
  • 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.

Requests may be submitted by mail in writing to the CDRH Standards program at the address below or electronically through CDRHStandardsStaff@fda.hhs.gov.

CDRH Standards Program
Office of the Center Director
Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO66-5514
Silver Spring, MD 20993-0002
 

Page Last Updated: 01/19/2017
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