§812.66. Significant risk device determinations.
21 C.F.R. § 812.66
If an IRB determines that an investigation, presented for approval under § 812.2(b)(1)(ii), involves a significant risk device, it shall so notify the investigator and, where appropriate, the sponsor. A sponsor may not begin the investigation except as provided in § 812.30(a).
Notes, amendments, and revision history
Amendments
[46 FR 8957, Jan. 27, 1981]
Authority
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
Source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.
Amendments
[46 FR 8957, Jan. 27, 1981]