[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: 21CFR3.4]
[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. 3.4 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) In some situations, it is not possible to determine, with
reasonable certainty, which one mode of action will provide a greater
contribution than any other mode of action to the overall therapeutic
effects of the combination product. In such a case, the agency will
assign the combination product to the agency component that regulates
other combination products that present similar questions of safety and
effectiveness with regard to the combination product as a whole. When
there are no other combination products that present similar questions
of safety and effectiveness with regard to the combination product as a
whole, the agency will assign the combination product to the agency
component with the most expertise related to the most significant safety
and effectiveness questions presented by the combination product.
(c) 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.
[56 FR 58756, Nov. 21, 1991, as amended at 70 FR 49861, Aug. 25, 2005]
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