21 CFR 812.66

§ 812.66 Significant risk device determinations.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 812.66, § 812.66 Significant risk device determinations, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88838
Permanent ID: ys:prov:88838@1
SHA-256: 8dc5878c70d1322f65b17be05fbc0bad0089af339fd6a0928020a494601be837

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Full text

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).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.