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Regulations last checked for updates: May 22, 2025
Title 21 - Food and Drugs last revised: May 19, 2025
All Titles
Title 21
Chapter I
Part 812 - PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS
Subpart A [§ 812.1 - § 812.19] - Subpart A—General Provisions
Subpart B [§ 812.20 - § 812.38] - Subpart B—Application and Administrative Action
Subpart C [§ 812.40 - § 812.47] - Subpart C—Responsibilities of Sponsors
Subpart D [§ 812.60 - § 812.66] - Subpart D—IRB Review and Approval
Subpart E [§ 812.100 - § 812.119] - Subpart E—Responsibilities of Investigators
Subpart F - Subpart F [Reserved]
Subpart G [§ 812.140 - § 812.150] - Subpart G—Records and Reports
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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