§ 812.66. Significant risk device determinations.
48 words·~1 min read·
/us/cfr/t21/s§ 812.66·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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]