§ 360h–1. Program to improve the device recall system

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.

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.

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.