eCFR Reference Browser

---

title: "21 CFR §812.42"

source: "https://www.ecfr.gov/current/title-21/section-812.42"

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: "C"

subpart_subject: "Responsibilities of Sponsors"

section_number: "812.42"

section_subject: "FDA and IRB approval."

cfr_reference: "21 CFR 812.42"

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 sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both approved the application or supplemental application relating to the investigation or part of an investigation.

§812.42 - FDA and IRB approval.