---
kind: "section"
citation: "21 U.S.C. § 360h–1"
title: "21"
title_heading: "Food and Drugs"
number: "360h–1"
heading: "Program to improve the device recall system"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360h-1"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §360h–1. Program to improve the device recall system

- (a) **In general—** The [Secretary](/usc/21/321.md?p=d) shall—
  - (1) establish a program to routinely and systematically assess information relating to [device](/usc/21/321.md?p=h-1) recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe [devices](/usc/21/321.md?p=h-1);
  - (2) clarify procedures for conducting [device](/usc/21/321.md?p=h-1) recall audit checks to improve the ability of investigators to perform those checks in a consistent manner;
  - (3) develop detailed criteria for assessing whether a [person](/usc/21/321.md?p=e) performing a [device](/usc/21/321.md?p=h-1) recall has performed an effective correction or action plan for the recall; and
  - (4) document the basis for each termination by the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration of a [device](/usc/21/321.md?p=h-1) recall.
- (b) **Assessment content—** The program established under [subsection (a)(1)](#a-1) shall, at a minimum, identify—
  - (1) trends in the number and types of [device](/usc/21/321.md?p=h-1) recalls;
  - (2) [devices](/usc/21/321.md?p=h-1) that are most frequently the subject of a recall; and
  - (3) underlying causes of [device](/usc/21/321.md?p=h-1) recalls.
- (c) **Definition—** In this section, the term “recall” means—
  - (1) the removal from the market of a [device](/usc/21/321.md?p=h-1) pursuant to an order of the [Secretary](/usc/21/321.md?p=d) under subsection (b) or (e) of [section 360h of this title](/usc/21/360h.md); or
  - (2) the correction or removal from the market of a [device](/usc/21/321.md?p=h-1) at the initiative of the [manufacturer](/usc/21/360hh.md?p=3) or importer of the [device](/usc/21/321.md?p=h-1) that is required to be reported to the [Secretary](/usc/21/321.md?p=d) under [section 360i(g) of this title](/usc/21/360i.md?p=g).

## Source credit

(June 25, 1938, ch. 675, § 518A, as added Pub. L. 112–144, title VI, § 605, July 9, 2012, 126 Stat. 1053; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(K), Dec. 13, 2016, 130 Stat. 1154.)

## Notes

### Editorial Notes

### Amendments

2016—Subsecs. (c), (d). Pub. L. 114–255 redesignated subsec. (d) as (c) and struck out former subsec. (c). Prior to amendment, text read as follows: “The Secretary shall document the basis for the termination by the Food and Drug Administration of a device recall.”