U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

All TitlesTitle 21Chapter IPart 3Subpart A - Subpart A—Assignment of Agency Component for Review of Premarket Applications
§ 3.1 - Purpose.
§ 3.2 - Definitions.
§ 3.3 - Scope.
§ 3.4 - Designated agency component.
§ 3.5 - Procedures for identifying the designated agency component.
§ 3.6 - Product jurisdiction officer.
§ 3.7 - Request for designation.
§ 3.8 - Letter of designation.
§ 3.9 - Effect of letter of designation.
§ 3.10 - Stay of review time.
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