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Regulations last checked for updates: May 23, 2025
Title 21 - Food and Drugs last revised: May 19, 2025
All Titles
Title 21
Chapter I
Part 812
Subpart B - Subpart B—Application and Administrative Action
§ 812.20 - Application.
§ 812.25 - Investigational plan.
§ 812.27 - Report of prior investigations.
§ 812.28 - Acceptance of data from clinical investigations conducted outside the United States.
§ 812.30 - FDA action on applications.
§ 812.35 - Supplemental applications.
§ 812.36 - Treatment use of an investigational device.
§ 812.38 - Confidentiality of data and information.
authority:
21 U.S.C. 331
,
351
,
352
,
353
,
355
,
360
,
360
c-360f,
360
h-360j,
360
hh-360pp,
360
rr-360ss,
360
bbb-8b,
371
,
372
,
374
,
379e
,
381
,
382
;
42 U.S.C. 216
,
241
,
262
source:
45 FR 3751, Jan. 18, 1980, unless otherwise noted.
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