21 CFR 812.62
§ 812.62 IRB approval.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 812.62, § 812.62 IRB approval, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88835
- Permanent ID
ys:prov:88835@1- SHA-256
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Full text
(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all investigations covered by this part.
(b) If no IRB exists or if FDA finds that an IRB's review is inadequate, a sponsor may submit an application to FDA.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.