Discontinuance or interruption in the production of medical devices

A manufacturer of a device that— A notice required under subsection (a) shall be submitted to the Secretary— To the maximum extent practicable, subject to paragraph (2), the Secretary shall distribute, through such means as the Secretary determines appropriate, information on the discontinuance or interruption of the manufacture of devices reported under subsection (a) to appropriate organizations, including physician, health provider, patient organizations, and supply chain partners, as appropriate and applicable, as described in subsection (g). The Secretary may choose not to make information collected under this section publicly available pursuant to this section if the Secretary determines that disclosure of such information would adversely affect the public health, such as by increasing the possibility of unnecessary over purchase of product, component parts, or other disruption of the availability of medical products to patients. Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18. If a person fails to submit information required under subsection (a) in accordance with subsection (b)— If, based on notifications described in subsection (a) or (h) or any other relevant information, the Secretary concludes that there is, or is likely to be, a shortage of an 11 So in original. Probably should be “a”. device, the Secretary shall, as appropriate— The Secretary shall establish and maintain an up-to-date list of devices that are determined by the Secretary to be in shortage in the United States. For each device included on the list under paragraph (1), the Secretary shall include the following information: The reason for the shortage, as determined by the Secretary, selecting from the following categories: Subject to subparagraphs (B) and (C), the Secretary shall make the information in the list under paragraph (1) publicly available. Nothing in this subsection shall be construed to alter or amend section 1905 of title 18 or section 552(b)(4) of title 5. The Secretary may elect not to make information collected under this subsection publicly available if the Secretary determines that disclosure of such information would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of the device to patients). The Secretary may receive voluntary notifications from a manufacturer of a device that is life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery, or any other device the Secretary determines to be critical to the public health, pertaining to a permanent discontinuance in the manufacture of the device (except for any discontinuance as a result of an approved modification of the device) or an interruption of the manufacture of the device that is likely to lead to a meaningful disruption in the supply of that device in the United States, and the reasons for such discontinuance or interruption. Nothing in this section shall be construed to affect the authority of the Secretary on March 27, 2020, to expedite the review of devices under section 360e of this title, section 360e–3 of this title relating to the priority review program for devices, and section 360bbb–3 of this title relating to the emergency use authorization authorities. In this section: The term “meaningful disruption”— The term “shortage”, with respect to a device, means a period of time when the demand or projected demand for the device within the United States exceeds the supply of the device.