21 Food and Drugs 1 2000-04-01 2000-04-01 false Scope. 3.3 Section 3.3 Food and Drugs FOOD AND DRUG ADMINISTRATION,DEPARTMENT OF HEALTH ANDHUMAN SERVICES GENERAL PRODUCT JURISDICTION Assignment of Agency Component for Review of Premarket Applications
ยง 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.