[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR3.1]
[Page 55]
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 (Public
Law 101-629) and amended by section 204 of the Medical Device User Fee
and Modernization Act of 2002 (Public Law 107-250), 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.
[56 FR 58756, Nov. 21, 1991, as amended by 68 FR 37077, June 23, 2003]
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