21 U.S.C. § 360h–1 — Program to improve the device recall system
submitted 88 years ago by Pub. L. 112-144 to r/title-21-FOOD-AND-DRUGS · 221 words · no verdicts yet
The FDA must build a program that tracks device recalls and finds ways to reduce risks. The program must spot trends, identify the most-recalled devices, and find recall causes. The FDA must also document why it ends each recall.
(a) In general. The FDA must: (1) set up a program that routinely and systematically reviews information about device recalls, and use that information to proactively find ways to reduce the health risks of defective or unsafe devices; (2) clarify how investigators should conduct device recall audit checks, so they do it consistently; (3) create detailed criteria for judging whether a person* carrying out a recall has done an effective job correcting the problem; and (4) write down the reasons every time the FDA ends a device recall.
(b) Assessment content. The program from subsection (a)(1) must, at minimum, identify: (1) trends in how many recalls happen and what types they are; (2) which devices get recalled most often; and (3) what underlying causes lead to recalls.
(c) Definition. In this section, a "recall" means either: (1) the FDA ordering a device removed from the market under section 360h(b) or (e); or (2) a manufacturer or importer voluntarily correcting or removing a device from the market, when that action must be reported to the FDA under section 360i(g).
The Secretary* shall—
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;
clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner;
develop detailed criteria for assessing whether a person* performing a device recall has performed an effective correction or action plan for the recall; and
document the basis for each termination by the Food* and Drug* Administration of a device recall.
The program established under subsection (a)(1) shall, at a minimum, identify—
trends in the number and types of device recalls;
devices that are most frequently the subject of a recall; and
underlying causes of device recalls.
In this section, the term “recall” means—
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
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.
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.)
- 1938Enacted · Pub. L. 112-144 · 126 Stat. 1053
- 2016Amended · Pub. L. 114-255 · 130 Stat. 1154
A history note hasn’t been published yet. The record shows enactment by Pub. L. 112-144 on 1938-06-25.
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