21 U.S.C. § 360h–1 — Program to improve the device recall system

1. (a)In generalThe Secretary shall—
   1. (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. (2)clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner;
   3. (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. (4)document the basis for each termination by the Food and Drug Administration of a device recall.
2. (b)Assessment contentThe program established under subsection (a)(1) shall, at a minimum, identify—
   1. (1)trends in the number and types of device recalls;
   2. (2)devices that are most frequently the subject of a recall; and
   3. (3)underlying causes of device recalls.
3. (c)DefinitionIn this section, the term “recall” means—
   1. (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. (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.