1. Regulations
  2. title 21
  3. chapter I-i7
  4. part 812
  5. subpart D
  6. § 812.66

View all text of Subpart D [§ 812.60 - § 812.66]

§ 812.66 - Significant risk device determinations.

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).

[46 FR 8957, Jan. 27, 1981]

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 812.66