21 CFR 56.101
§ 56.101 Scope.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 56.101, § 56.101 Scope, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83473
- Permanent ID
ys:prov:83473@1- SHA-256
cec04e35da430707c1eb2017ec91bdab2f8015fa1580e4c66fbec70d47918580
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) This part contains the general standards for the composition, operation, and responsibility of an Institutional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. Compliance with this part is intended to protect the rights and welfare of human subjects involved in such investigations.
(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.