21 U.S.C. § 360h–1: Program to improve the…

Summary

The Secretary must create a program to regularly study device recalls and use that information to find ways to reduce health risks from defective or unsafe devices. The Secretary must also set clear steps for how investigators do recall audit checks, make rules for judging whether a company’s recall actions worked, and record why the FDA ends each recall. The study must at least find trends in how many and what types of recalls occur, which devices are recalled most often, and the main causes of recalls. “Recall” means either a device removed under an official order from the Secretary, or a fix or removal done by the manufacturer or importer that must be reported to the Secretary.

Title 21, §360h–1

Food and Drugs, Source: USLM XML via OLRC

(a)In general

The Secretary shall—

(1)establish a program to routinely and systematically assess information relating to device recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices;

(2)clarify procedures for conducting device 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 performing a device recall has performed an effective correction or action plan for the recall; and

(4)document the basis for each termination by the Food and Drug Administration of a device recall.

(b)Assessment content

The program established under subsection (a)(1) shall, at a minimum, identify—

(1)trends in the number and types of device recalls;

(2)devices that are most frequently the subject of a recall; and

(3)underlying causes of device recalls.

(c)Definition

In this section, the term “recall” means—

(1)the removal from the market of a device pursuant to an order of the Secretary under subsection (b) or (e) of section 360h of this title; or

(2)the correction or removal from the market of a device at the initiative of the manufacturer or importer of the device that is required to be reported to the Secretary under section 360i(g) of this title.

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.”

§360h–1 Program to Improve the Device Recall System

Summary

Title 21, §360h–1

Notes & Related Subsidiaries

Editorial Notes

Amendments

Citations & Metadata