[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: 21CFR3.1]

[Page 20]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 3--PRODUCT JURISDICTION--Table of Contents
 
   Subpart A--Assignment of Agency Component for Review of Premarket 
                              Applications
 
Sec. 3.1  Purpose.


    This regulation relates to agency management and organization and 
has two purposes. The first is to implement section 503(g) of the act, 
as added by section 16 of the Safe Medical Devices Act of 1990 (Pub. L. 
101-629), by specifying how FDA will determine the organizational 
component within FDA designated to have primary jurisdiction for the 
premarket review and regulation of products that are comprised of any 
combination of a drug and a device; a device and a biological; a 
biological and a drug; or a drug, a device and a biological. This 
determination will eliminate, in most cases, the need to receive 
approvals from more than one FDA component for such combination 
products. The second purpose of this regulation is to enhance the 
efficiency of agency management and operations by providing procedures 
for determining which agency component will have primary jurisdiction 
for any drug, device, or biological product where such jurisdiction is 
unclear or in dispute. Nothing in this section prevents FDA from using 
any agency resources it deems necessary to ensure adequate review of the 
safety and effectiveness of any product, or the substantial equivalence 
of any device to a predicate device.