Code of Federal Regulations (Last Updated: July 5, 2024) |
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 |
§ 3.3 - Scope.
Latest version.
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§ 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.