Significant risk device determinations.

21 C.F.R. § 812.66
in effectEffective: 2024-07-01
Sign in to generate a plain English summaryAsk Belisarius Agent
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).

Starting a business? Corpus forms LLCs in all 50 states and DC.