21 CFR § 812.10 - Waivers.

---
identifier: "/us/cfr/t21/s812.10"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 812.10 - Waivers."
title_number: 21
title_name: "Food and Drugs"
section_number: "812.10"
section_name: "Waivers."
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"
---


# 812.10 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.

(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.