eCFR Reference Browser

---

title: "21 CFR §812.64"

source: "https://www.ecfr.gov/current/title-21/section-812.64"

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: "812.64"

section_subject: "IRB's continuing review."

cfr_reference: "21 CFR 812.64"

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"

---

The IRB shall conduct its continuing review of an investigation in accordance with part 56.

§812.64 - IRB's continuing review.