21 C.F.R. § 812.66
Current through September 30, 2024
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) .
21 C.F.R. §812.66