[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.33]

[Page 43]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
 
Subpart B--Redelegations of Authority from the Commissioner of Food and 
                                  Drugs
 
Sec. 5.33  Premarket approval of a product that is or contains a biologic, a device, or a drug.

    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, Center for Devices and Radiological Health, or Center for Drug 
Evaluation and Research 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:
    (a) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER) and the Director, Office of Biological 
Product Review, CBER.
    (b) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), and the Director, Office of Device 
Evaluation, CDRH.
    (c) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER); and the Directors of the Offices of Drug 
Evaluation I, II, III, IV, and V, Office of Review Management, CDER.

[56 FR 58759, Nov. 21, 1991, as amended at 62 FR 2555, Jan. 17, 1997; 62 
FR 67271, Dec. 24, 1997]