§360h–1 — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary must create a program that regularly studies device recall information and uses it to find ways to reduce health risks from unsafe or defective devices. The Secretary must also make clear how investigators should do recall audit checks, set rules to decide if a recall fix worked, and write down why the FDA ends any recall. The program must look for trends in recalls, the devices recalled most often, and the reasons recalls happen. A "recall" means either an FDA-ordered removal from the market or a manufacturer-led correction or removal that must be reported to the FDA.

Title 21, §360h–1

Food and Drugs — Source: USLM XML via OLRC

(a)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)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)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