PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.

SEC. 605. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM. Chapter V is amended by inserting after section 518 (21 U.S.C. 360h) the following: “SEC. 518A. [21 U.S.C. 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) Termination of Recalls. The Secretary shall document the basis for the termination by the Food and Drug Administration of a device recall. “(d) 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 518; 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 519(g).” .