§ 360h–1 — Program To Improve The Device Recall System

(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.