US Code
Part A— Drugs and Devices
§ 360h–1. Program to improve the device recall system

(a) In generalThe 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 contentThe 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) DefinitionIn 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.

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