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.
Subpart B [Reserved]
Authority: 21 U.S.C. 321, 351, 353, 355, 360, 360c-360f, 360h-360j, 360gg-360ss, 360bbb-2, 371(a), 379e, 381, 394; 42 U.S.C. 216, 262, 264. Source: 56 FR 58756, Nov. 21, 1991, unless otherwise noted.