§ 812.66 Significant risk device determinations.
Current through Sep 8, 2026 · Read all of Part 812
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]