Sec. 605. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM
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## SEC. 605 PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM Chapter V is amended by inserting after section 518 (21 U.S.C. 360h) the following: > > ## “SEC. 518A PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM > > **[**[21 U.S.C. 360h-1](/us/usc/t21/s360h-1)**]** > > > ### “(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)of section 518; 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 519(g).” > .
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