Part 3 — Product Jurisdiction

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.