Title 21

PART 3 SUBPART A

Subpart A - Assignment of Agency Component for Review of Premarket Applications

• 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.
• 56 FR 58756, Nov. 21, 1991, unless otherwise noted.

21:1.0.1.1.3.1.63.1	SECTION 3.1	3.1 Purpose.
21:1.0.1.1.3.1.63.2	SECTION 3.2	3.2 Definitions.
21:1.0.1.1.3.1.63.3	SECTION 3.3	3.3 Scope.
21:1.0.1.1.3.1.63.4	SECTION 3.4	3.4 Designated agency component.
21:1.0.1.1.3.1.63.5	SECTION 3.5	3.5 Procedures for identifying the designated agency component.
21:1.0.1.1.3.1.63.6	SECTION 3.6	3.6 Product jurisdiction officer.
21:1.0.1.1.3.1.63.7	SECTION 3.7	3.7 Request for designation.
21:1.0.1.1.3.1.63.8	SECTION 3.8	3.8 Letter of designation.
21:1.0.1.1.3.1.63.9	SECTION 3.9	3.9 Effect of letter of designation.
21:1.0.1.1.3.1.63.10	SECTION 3.10	3.10 Stay of review time.

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