21 U.S. Code § 360h–1 - Program to improve the device recall system
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(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
(b) Assessment content
The program established under subsection (a)(1) shall, at a minimum, identify—
(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
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