1. Regulations
  2. title 21
  3. chapter I-i7
  4. part 812
  5. subpart C
  6. § 812.45

View all text of Subpart C [§ 812.40 - § 812.47]

§ 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.

AUTHORITY: 21 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.

SOURCE: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.

CITE AS: 21 CFR 812.45