21 CFR Part 812 · Investigational Device Exemptions

§ 812.64 IRB's continuing review

Subpart D - IRB Review and Approval Official text on eCFR Amendment history

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

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

FDA guidance that cites § 812.64

Considerations When Transferring Clinical Investigation Oversight to Another IRB: Guidance for IRBs, Clinical Investigators, and Sponsors 23 May 2014

Amendment history

Federal Register documents that created or amended this section.

46 FR 8957 27 Jan 1981