Subpart 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.