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SMG 1410.702

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - PRODUCT DESIGNATION

PREMARKET APPROVAL OF A PRODUCT THAT IS OR CONTAINS A BIOLOGIC, A DEVICE, OR A DRUG

Effective Date: 01/05/2010

[PDF Version]

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

For a product that is or contains a biologic, a device, or a drug, the following officials in the Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), or Center for Drug Evaluation and Research (CDER) who currently hold delegated premarket approval authority for biologics, devices, or drugs, respectively, are hereby delegated all the authorities necessary for premarket approval of any product that is a biologic, a device, or a drug, or any combination of two or more of these products:

1. The Director and Deputy Directors, CBER, and the Directors of the Office of Blood Research and Review, Office of Vaccines Research and Review, Office of Cellular, Tissue and Gene Therapies, and Office of Compliance and Biologics Quality, CBER.

2. The Director and Deputy Directors, CDRH, the Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH, the Director, Program Operations Staff (POS), ODE, CDRH, the Division Directors, ODE, CDRH, and the Director and Deputy Directors, Office of Compliance (OC), CDRH, the Division Directors, OC, CDRH and the Director, Office of In Vitro Diagnostic Devices Evaluation and Safety (OIVD), CDRH.

For medical devices assigned to their respective organizations, the Director, POS, ODE, CDRH, the Chief, Premarket Approval Section, POS, ODE, CDRH, the Division Directors, ODE, CDRH, Director and the Deputy Director, OC, CDRH, Division Directors, OC, CDRH, Director and Deputy Director, OIVD, CDRH, the Division Directors, OIVD, CDRH, the Director and Deputy Director, OSB, CDRH, and the Division Directors, OSB, CDRH, are authorized to approve, disapprove, or withdraw approval of supplemental premarket applications.

3. The Director, the Deputy Director, and the Directors, Office of New Drug and Office of Pharmaceutical Science, CDER; and 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.

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 January 5, 2010.

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial01/05/2010N/aCDRH/OMO/DEMO/AMBMargaret A. Hamburg, M.D., Commissioner of Food and Drugs