Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 1 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / SUBCHAPTER A - GENERAL
/ PART 3 - PRODUCT JURISDICTION
/ Subpart A - Assignment of Agency Component for Review of Premarket Applications / § 3.3 Scope.
§ 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.