21 CFR 812.62 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — Investigational Device Exemptions (§ 812.1 To § 812.150) — Irb Review And Approval (§ 812.60 To § 812.66) — IRB approval.

4 Aug 2016

(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.

21 CFR 812.62
[46 FR 8957, Jan. 27, 1981]