Regulations last checked for updates: Nov 25, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024
All TitlesTitle 21Chapter IPart 812Subpart C - Subpart C—Responsibilities of Sponsors
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
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