FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY
REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH
MEDICAL DEVICE RECALL AUTHORITY
Effective Date: 03/23/2011
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
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 APPROVED||LOCATION OF CHANGE HISTORY||CONTACT||APPROVING OFFICIAL|
|Initial||06/23/2009||N/a||OC/OO/OM/OMP||Commissioner of Food and Drugs|
|Revision||03/23/2011||N/a||CDRH/OMO/DEMO/AMB||Margaret A. Hamburg, M.D., Commissioner of Food and Drugs|