21 CFR Part 56 sets forth FDA requirements for IRBs that review studies of drugs (21 CFR 312), devices (21 CFR 812), and biologics. Companion regulations include 21 CFR 50 (informed consent) and 21 CFR 54 (financial disclosure).
FDA-regulated studies often must comply with both 21 CFR 56 and 45 CFR 46 simultaneously. Where requirements differ, the more protective standard generally applies.