GroundRules
21 CFR 3.3: Scope.
Where this section sits in the code
- Title 21—Food and Drugs
- 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
This section applies to:
(a) Any combination product, or
(b) Any product where the agency component with primary jurisdiction is unclear or in dispute.
Collected 2026-08-27T02:24:47Z. Source file · JSON