eCFR Reference Browser

---

title: "21 CFR §812.62"

source: "https://www.ecfr.gov/current/title-21/section-812.62"

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: "D"

subpart_subject: "IRB Review and Approval"

section_number: "812.62"

section_subject: "IRB approval."

cfr_reference: "21 CFR 812.62"

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)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.

§812.62 - IRB approval.