Regulation Text
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) .
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.