[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR3.4]

[Page 43]
 
                        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. 3.4  Designated agency component.

    (a) To designate the agency component with primary jurisdiction for 
the premarket review and regulation of a combination product, the agency 
shall determine the primary mode of action of the product. Where the 
primary mode of action is that of:
    (1) A drug (other than a biological product), the agency component 
charged with premarket review of drugs shall have primary jurisdiction;
    (2) A device, the agency component charged with premarket review of 
devices shall have primary jurisdiction;
    (3) A biological product, the agency component charged with 
premarket review of biological products shall have primary jurisdiction.
    (b) The designation of one agency component as having primary 
jurisdiction for the premarket review and regulation of a combination 
product does not preclude consultations by that component with other 
agency components or, in appropriate cases, the requirement by FDA of 
separate applications.