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21 U.S.C. § 360h–1 — Program to improve the device recall system
Federal law — U.S. Code and appendices · legal_authorities
**(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) 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 360h of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360h&num=0&edition=prelim); 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360i/g&num=0&edition=prelim).
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360h–1
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Stable record: federal_law:legal_authorities:record_usc_51f03938cff598044c462d79
Source file: Laws/federal/codes/united-states-code/title-21/section-360h1-program-to-improve-the-device-recall-system--348b98a75b.md
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Passage SHA-256: d5327bc55c1bba7213832a44fb4f20c489b0c0f00a5f32de591296662ff73f81
Source location: Title 21, Chapter 9, § 360h–1; chapter-009-federal-food-drug-and-cosmetic-act.md
Stored source content
**(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) 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 360h of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360h&num=0&edition=prelim); 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360i/g&num=0&edition=prelim).
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Notification** If the Secretary determines that—
(1) a device intended for human use which is introduced or delivered for introduction into interstate commerce for commercial distribution presents an unreasonable risk of substantial harm to the public health, and
(2) notification under this subsection is necessary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this chapter (other than this section) to eliminate such risk,
the Secretary may issue such order as may be necessary to assure that adequate notification is provided in an appropriate form, by the persons and means best suited under the circumstances involved, to all health professionals who prescribe or use the device and to any other person (including manufacturers, importers, distributors, retailers, and device users) who should properly receive such notification in order to eliminate such risk. An order under this subsection shall require that the individuals subject to the risk with respect to which the order is to be issued be included in the persons to be notified of the risk unless the Secretary determines that notice to such individuals would present a greater danger to the health of such individuals than no such notification. If the Secretary makes such a determination with respect to such individuals, the order shall require that the health professionals who prescribe or use the device provide for the notification of the individuals whom the health professionals treated with the device of the risk presented by the device and of any action which may be taken by or on behalf of such individuals to eliminate or reduce such risk. Before issuing an order under this subsection, the Secretary shall consult with the persons who are to
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360h
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.