21 C.F.R. § 3.3 Scope.
Title 21 - Food and Drugs
This section applies to: (a) Any combination product, or (b) Any product where the agency component with primary jurisdiction is unclear or in dispute.
Title 21: Food and Drugs
PART 3—PRODUCT JURISDICTION
Subpart A—Assignment of Agency Component for Review of Premarket Applications
§ 3.3 Scope.
