Code of Federal Regulations · Section
§ 812.66 — Significant Risk Device Determinations
21 C.F.R. § 812.66
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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).
Authorizing Statute
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Regulations42 U.S.C. § 216
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Prohibited acts21 U.S.C. § 331