21 CFR Part 3 - 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.