U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. CPG Sec. 300.700 Direct Reference Authority for Class III Medical Devices Without a Premarket Notification (510(k)) or an Approved Premarket Approval Application (PMA) REVOKED
  1. Search for FDA Guidance Documents

COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 300.700 Direct Reference Authority for Class III Medical Devices Without a Premarket Notification (510(k)) or an Approved Premarket Approval Application (PMA) REVOKED October 2002

Final
Docket Number:
FDA-2013-S-0610
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Office of Regulatory Affairs

Revocation/Deletion

Sec. 300.700 Direct Reference Authority for Class III Medical Devices Without a Premarket Notification (510(k)) or an Approved Premarket Approval Application (PMA)

REVOKED effective October 07, 2002 per Federal Register dated September 05, 2002 (67 FR 56850)

Issued: 2/26/91
Revised: 3/95
REVOKED: 10/07/2002 (Federal Register 09/05/2002)

Page created 10/15/2002 (tc)

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-S-0610.