(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.
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) ofsection
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.
The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.
The most recent Classification Table update that we have noticed was Tuesday, August 13, 2013
An empty table indicates that we see no relevant changes listed in the classification tables. If you suspect that our system may be missing something, please double-check with the Office of the Law Revision Counsel.