---
kind: "section"
citation: "21 C.F.R. § 812.10"
title: "21"
number: "812.10"
heading: "Waivers."
url: "https://uscodex.org/cfr/21/812.10"
---

# §812.10. Waivers.

- (a) **Request.** A sponsor may request FDA to waive any requirement of this part. A waiver request, with supporting documentation, may be submitted separately or as part of an application to the address in [§ 812.19](/cfr/21/812.19.md).
- (b) **FDA action.** FDA may by letter grant a waiver of any requirement that FDA finds is not required by the act and is unnecessary to protect the rights, safety, or welfare of human subjects.
- (c) **Effect of request.** Any requirement shall continue to apply unless and until FDA waives it.

## Notes

### 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.