Title 21

PART 3

Part 3 - Product Jurisdiction

PART 3 - PRODUCT JURISDICTION 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.

21:1.0.1.1.3.1SUBPART A
Subpart A - Assignment of Agency Component for Review of Premarket Applications
21:1.0.1.1.3.1.63.1SECTION 3.1
   3.1 Purpose.
21:1.0.1.1.3.1.63.2SECTION 3.2
   3.2 Definitions.
21:1.0.1.1.3.1.63.3SECTION 3.3
   3.3 Scope.
21:1.0.1.1.3.1.63.4SECTION 3.4
   3.4 Designated agency component.
21:1.0.1.1.3.1.63.5SECTION 3.5
   3.5 Procedures for identifying the designated agency component.
21:1.0.1.1.3.1.63.6SECTION 3.6
   3.6 Product jurisdiction officer.
21:1.0.1.1.3.1.63.7SECTION 3.7
   3.7 Request for designation.
21:1.0.1.1.3.1.63.8SECTION 3.8
   3.8 Letter of designation.
21:1.0.1.1.3.1.63.9SECTION 3.9
   3.9 Effect of letter of designation.
21:1.0.1.1.3.1.63.10SECTION 3.10
   3.10 Stay of review time.
21:1.0.1.1.3.2SUBPART B
Subpart B [Reserved]