Home
gpo.gov
govinfo.gov

e-CFR Navigation Aids

Browse

Simple Search

Advanced Search

 — Boolean

 — Proximity

 

Search History

Search Tips

Corrections

Latest Updates

User Info

FAQs

Agency List

Incorporation By Reference

eCFR logo

Related Resources

Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We have made big changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom right of each page!

e-CFR data is current as of February 25, 2021

Title 21Chapter ISubchapter APart 3Subpart A → §3.4


Title 21: Food and Drugs
PART 3—PRODUCT JURISDICTION
Subpart A—Assignment of Agency Component for Review of Premarket Applications


§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]

Need assistance?