21 CFR § 812.42 - FDA and IRB approval.

---
identifier: "/us/cfr/t21/s812.42"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 812.42 - FDA and IRB approval."
title_number: 21
title_name: "Food and Drugs"
section_number: "812.42"
section_name: "FDA and 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"
---


# 812.42 FDA and IRB approval.

A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both approved the application or supplemental application relating to the investigation or part of an investigation.

[46 FR 8957, Jan. 27, 1981]