21 CFR § 812.62 - IRB approval.

---
identifier: "/us/cfr/t21/s812.62"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 812.62 - IRB approval."
title_number: 21
title_name: "Food and Drugs"
section_number: "812.62"
section_name: "IRB approval."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "812"
part_name: "INVESTIGATIONAL DEVICE EXEMPTIONS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360hh-360pp, 360rr-360ss, 360bbb-8b, 371, 372, 374, 379e, 381, 382; 42 U.S.C. 216, 241, 262."
regulatory_source: "45 FR 3751, Jan. 18, 1980, unless otherwise noted."
cfr_part: "812"
---


# 812.62 IRB approval.

(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.

[46 FR 8957, Jan. 27, 1981]