FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY
REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH
TEMPORARY SUSPENSION OF A MEDICAL DEVICE APPLICATION
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 under Section 515(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(e)), to determine that there is reasonable probability that continuation of the distribution of a device under an approved application would cause serious adverse health consequences or death, and upon making such a determination, to issue an order to temporarily suspend the approval of an application:
1. Center for Devices and Radiological Health (CDRH):
a. Director and Deputy Directors, CDRH
b. Director and Deputy Directors, Office of Compliance, CDRH
c. Director and Deputy Directors, Office of Device Evaluation, CDRH
d. Director and Deputy Directors, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH
2. Center for Drug Evaluation and Research (CDER):
a. Director and Deputy Directors, CDER
b. Director, Office of New Drugs (OND), CDER
c. Director, Office of Pharmaceutical Science (OPS), CDER
d. Directors, Office of Drug Evaluation I, II, III, and IV; Office of Antimicrobial Products; and Office of Oncology Drug Products, OND, CDER
e. Director and Deputy Director, Office of Generic Drugs, OPS, CDER
f. Director and Deputy Director, Office of Compliance, CDER
3. Center for Biologics Evaluation and Research (CBER):
a. Director and Deputy Director, CBER
b. 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||06/23/2011||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|