§ 360h–1. Program to improve the device recall system
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The Secretary shall— 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.
The program established under subsection (a)(1) shall, at a minimum, identify— 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. In this section, the term “recall” means— 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 . ( June 25, 1938, ch. 675, § 518A , as added Pub. L. 112–144, title VI, § 605 , July 9, 2012 , 126 Stat. 1053 ; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(K) , Dec. 13, 2016 , 130 Stat. 1154 .)
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- Pub. L. 112-144
- 126 Stat. 1053
- 130 Stat. 1154
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§ 360h–1
Program to improve the device recall system
Stat. Comp.×2
Pub. L.Pub. L. 112-144
Stat.126 Stat. 1053
Stat.130 Stat. 1154
Cites 4Cited by 2 across 1 source