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

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

Page Last Updated: 01/19/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English