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§ 812.45 Informing investigators.

21 CFR 812.45

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Citation21 CFR 812.45
CorpusDaily eCFR
Displayed edition2026-06-01
Last updated2026-06-01

§ 812.45 Informing investigators.

A sponsor shall supply all investigators participating in the investigation with copies of the investigational plan and the report of prior investigations of the device.

Authority21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360hh-360pp, 360rr-360ss, 360bbb-8b, 371, 372, 374, 379e, 381, 382; 42 U.S.C. 216, 241, 262.
Source45 FR 3751, Jan. 18, 1980, unless otherwise noted.