[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: 21CFR3.3]
[Page 57]
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. 3.3 Scope.
This section applies to:
(a) Any combination product, or
(b) Any product where the agency component with primary jurisdiction
is unclear or in dispute.
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