[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.