eCFR Reference Browser

---

title: "21 CFR §810.1"

source: "https://www.ecfr.gov/current/title-21/section-810.1"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "810"

part_subject: "MEDICAL DEVICE RECALL AUTHORITY"

subpart_code: "A"

subpart_subject: "General Provisions"

section_number: "810.1"

section_subject: "Scope."

cfr_reference: "21 CFR 810.1"

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"

---

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.

§810.1 - Scope.