---
kind: "section"
citation: "21 C.F.R. § 812.62"
title: "21"
number: "812.62"
heading: "IRB approval."
url: "https://uscodex.org/cfr/21/812.62"
---

# §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.

## Notes

### Amendments

[46 FR 8957, Jan. 27, 1981]

### Authority

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.

### Source

Source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.

### Amendments

[46 FR 8957, Jan. 27, 1981]