21 USC § 360h–1 - Program to improve the device recall system

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Current through Pub. L. 112-173. (See Public Laws for the current Congress.)

(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) 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.

This preliminary release may be subject to further revision before it is released again as a final version. As with other online versions of the Code, the U.S. Code Classification Tables should be consulted for the latest laws affecting the Code. Those using the USCPrelim should verify the text against the printed slip laws available from GPO (Government Printing Office), the laws as shown on THOMAS (a legislative service of the Library of Congress), and the final version of the Code when it becomes available.

Current through Pub. L. 112-173. (See Public Laws for the current Congress.)

Source

(June 25, 1938, ch. 675, § 518A, as added Pub. L. 112–144, title VI, § 605,July 9, 2012, 126 Stat. 1053.)

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 Wednesday, December 26, 2012

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21 USC	Description of Change	Session Year	Public Law	Statutes at Large
§ 360h-1	new	2012	112-144 [Sec.] 605 "518A"	126 Stat. 1053

21 USC § 360h–1 - Program to improve the device recall system

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