21 CFR § 810.1 - Scope.

---
identifier: "/us/cfr/t21/s810.1"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 810.1 - Scope."
title_number: 21
title_name: "Food and Drugs"
section_number: "810.1"
section_name: "Scope."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "810"
part_name: "MEDICAL DEVICE RECALL AUTHORITY"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 332, 333, 334, 351, 352, 355, 360h, 360i, 371, 374, 375."
regulatory_source: "61 FR 59018, Nov. 20, 1996, unless otherwise noted."
cfr_part: "810"
---


# 810.1 Scope.

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.