10923. SIGNIFICANT RISK DEVICE DETERMINATIONS

10923 SIGNIFICANT RISK DEVICE DETERMINATIONS 10923.1 If an IRB determines that an investigation, presented for approval under § 10901.2(a)(2), 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 § 10910.1. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10923