21 U.S.C. § 360h-1

Current through P.L. 118-106 (published on www.congress.gov on 10/04/2024)

Section 360h-1 - Program to improve the device recall system

(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.

21 U.S.C. § 360h-1

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.

EDITORIAL NOTES

AMENDMENTS2016-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."