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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. The Director and Deputy Director, Center for Devices and Radiological Health (CDRH).
2. The Director and Deputy Director, Office of Compliance, CDRH.
3. The Director and Deputy Directors, Office of Device Evaluation, CDRH.
4. The Director and Deputy Director, Office of In Vitro Diagnostic Devices Evaluation and Safety, CDRH.
5. The Director, the Deputy Director, and the Directors, Office of New Drugs and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); 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; the Director and Deputy Director, Office of Generic Drugs, Office of Pharmaceutical Science, CDER; and the Director and Deputy Director, Office of Compliance, CDER.
6. The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Directors, 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 April 27, 2007.