CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL

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.

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.