eCFR Reference Browser

---

title: "21 CFR §812.10"

source: "https://www.ecfr.gov/current/title-21/section-812.10"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "812"

part_subject: "INVESTIGATIONAL DEVICE EXEMPTIONS"

subpart_code: "A"

subpart_subject: "General Provisions"

section_number: "812.10"

section_subject: "Waivers."

cfr_reference: "21 CFR 812.10"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§812.10 - Waivers.