• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

SMG 1410.412

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH

MEDICAL DEVICE RECALL AUTHORITY

Effective Date: 03/23/2011

[PDF Version]

1.  AUTHORITY DELEGATED AND TO WHOM DELEGATED.

The following officials, for medical devices assigned to their respective organizations, are authorized to perform all of the recall functions under Section 518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(e)), delegated to the Commissioner of Food and Drugs:

1.  Director and Deputy Directors, Center for Devices and Radiological Health (CDRH)

2.  Director and Deputy Directors, Office of Compliance, CDRH; and the Director and Deputy Directors, Office of In Vitro Diagnostic Devices Evaluation and Safety, CDRH

3.  Director and Deputy Directors, Center for Drug Evaluation and Research (CDER); Director, Office of New Drugs, CDER; Director, Office of Pharmaceutical Science, CDER; and Director and Deputy Director, Office of Compliance, CDER

4.  Director and Deputy Director, Center for Biologics Evaluation and Research (CBER); and Director and Deputy Director, Office of Compliance and Biologics Quality, CBER

2.  REDELEGATION.

These officials may not further redelegate this authority.

3.  EFFECTIVE DATE.

The Commissioner of Food and Drugs approved this delegation, via memorandum, on March 23, 2011.

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial06/23/2009N/aOC/OO/OM/OMPCommissioner of Food and Drugs
Revision03/23/2011N/aCDRH/OMO/DEMO/AMBMargaret A. Hamburg, M.D., Commissioner of Food and Drugs