FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY
REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH
Effective Date: 06/23/2009
1. AUTHORITIES DELEGATED AND TO WHOM DELEGATED.
For any class II or class III device (including any device that is or contains a drug or biologic), the failure of which would be reasonably likely to have serious adverse health consequences, or which is intended to be implanted in the human body for more than 1 year, or a life supporting or life sustaining device used outside a user facility, any of the following officials are authorized to require a manufacturer of such device to conduct postmarket surveillance:
1. The Director, Deputy Directors, and Associate Director for Regulations and Policy, Center for Devices and Radiological Health (CDRH).
2. The Director and Deputy Director, Office of Surveillance and Biometrics, (OSB), CDRH.
3. The Director and Deputy Director, Division of Postmarket Surveillance, OSB, and the Director, Issues Management Staff, OSB, CDRH. The Director and Deputy Directors, Office of Device Evaluation, CDRH.
4. The Director and Deputy Director, Office of Science and Engineering Laboratories, (OSEL), CDRH.
5. The Director and Deputy Director, Office of Communication, Education, and
Radiation Programs (OCER), CDRH.
6. The Director and Deputy Director, Office of Compliance, CDRH.
7. The Director and Deputy Director, Office of In Vitro Diagnostic Devices Evaluation and Safety, CDRH.
8. The Director, the Deputy Director, and the Directors, Office of New Drugs and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).
9. The Directors of the Offices of Drug Evaluation I, II, III, Office of Antimicrobial Products (OAP), Office of Nonprescription Products (ONP) and Office of Oncology Drug Products (OODP), Office of New Drugs, CDER.
10. The Director and Deputy Director, Office of Compliance, CDER.
11. The Director and Deputy Directors, Center for Biologics Evaluation and
12. The Director and Deputy Director, Office of Compliance and Biologics Quality, CBER.
13. The Directors and Deputy Directors, Office of Blood Research and Review, Office of Vaccines Research and Review, and Office of Cellular, Tissue and Gene Therapies, CBER.
These officials may not further redelegate these authorities.
3. EFFECTIVE DATE.
This delegation was signed by the Commissioner on June 23, 2009.
|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|