21 CFR Part 810 · Medical Device Recall Authority

§ 810.1 Scope

Subpart A - General Provisions Official text on eCFR Amendment history

Part 810 describes the procedures that the Food and Drug Administration will follow in exercising its medical device recall authority under section 518(e) of the Federal Food, Drug, and Cosmetic Act.

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 § 810.1

Distinguishing Medical Device Recalls from Medical Device Enhancements: Guidance for Industry and Food and Drug Administration Staff 15 Oct 2014

Amendment history

Federal Register documents that created or amended this section.

61 FR 59018 20 Nov 1996