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Regulations last checked for updates: Apr 30, 2025
Title 21 - Food and Drugs last revised: Apr 28, 2025
All Titles
Title 21
Chapter I
Part 3
Subpart A - 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.
authority:
21 U.S.C. 321
,
351
,
353
,
355
,
360
,
360
c-360f,
360
h-360j,
360
gg-360ss,
360
bbb-2,
371
,
379e
,
381
,
394
;
42 U.S.C. 216
,
262
,
264
source:
56 FR 58756, Nov. 21, 1991, unless otherwise noted.
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