SUBPART A—Assignment of Agency Component for Review of Premarket Applications (§3.1 to §3.10)
- 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.