21 C.F.R. · Food and Drugs
21 C.F.R. § 812.66

Significant risk device determinations.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 812.66 — Significant risk device determinations.

§ 812.66 Significant risk device determinations. 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]

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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21 C.F.R. § 812.66
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The regulatory text of 21 C.F.R. § 812.66 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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