Sec. 70531. Shortages of essential devices
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Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.) is amended by inserting after section 520 the following: A manufacturer or contract terminal sterilizer of an essential device shall notify the Secretary— in accordance with paragraph (3), when such manufacturer or sterilizer becomes aware of— a permanent discontinuance in the manufacture of the device (except for a permanent discontinuance as a result of an approved modification of the device); an interruption in the manufacture of the device that is likely to lead to a shortage or meaningful disruption in the supply of that device in the United States; or any other situation or circumstance that is likely to lead to a shortage or meaningful disruption in the supply of that device in the United States; and in accordance with paragraph (2)(C), of the reason for such discontinuance, interruption, or other situation or circumstance.
A notification under paragraph
(1)shall include each of the following: The name of the device, including the Device Identifier or National Product Code for the device, if applicable. The name of the manufacturer of the device. The reason for the notification, including whether any of the following reasons apply: Requirements related to complying with quality system regulations. Shortage of a material used in the manufacture of the device. Shortage of a component, part, or accessory of the device. Delay in shipping of the device. Increased demand for the device. Natural disaster. Cyber security. Facility closure. Other reasons as the Secretary deems appropriate. The estimated duration of the discontinuance, interruption, or other situation or circumstance. Any other information the manufacturer deems relevant. The notification required under paragraph
(1)shall be submitted, in a manner prescribed by the Secretary— no later than 6 months prior to the date of the discontinuance, interruption, or other situation or circumstance; or if compliance with subparagraph
(A)is not possible, as soon as is practicable, and in no case later than 5 business days after the manufacturer becomes aware of an event, situation, or circumstance requiring notification under paragraph (1). To the extent practicable, the Secretary shall distribute, through such means as the Secretary deems appropriate, information on any discontinuance, interruption, or other situation or circumstance described in subsection
(a)to appropriate organizations, including to hospitals, physicians and other health care providers, patients, and supply chain partners. The Secretary may choose not to make information collected under this section publicly available pursuant to this section if the Secretary determines that the disclosure of such information would adversely affect public health, such as by increasing the possibility of an unnecessary over-purchase 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, United States Code, or section 1905 of title 18, United States Code. If a person fails to submit information as required under subsection (a)— the Secretary shall issue a letter to such person setting forth the basis for noncompliance and informing such person of a failure to comply; within 30 calendar days from the issuance of a letter under paragraph (1), the person who receives such letter shall submit to the Secretary a written response to such letter setting forth the basis for noncompliance and providing information required under subsection (a); and not later than 45 calendar days after the issuance of a letter under paragraph (1), the Secretary shall make such letter and any response to such letter under paragraph
(2)available to the public on the public website of the Food and Drug Administration, with appropriate redactions made to protect information described in subsection (c), except that, if the Secretary determines that the letter under paragraph
(1)was issued in error or, after review of such response, the person had a reasonable basis for not notifying as required under subsection (a), the requirements of this paragraph shall not apply. If, based on notifications described in subsection
(a)or any other relevant information, the Secretary concludes that there is, or is likely to be, a shortage of a device described in subsection (a), the Secretary may— expedite the review of premarket submissions under sections 510(k), 513(f)(2), 515, and 520(m), that could help mitigate or prevent such shortage; or expedite an inspection or reinspection of an establishment that could help mitigate or prevent such shortage. The submission of a notification under subsection
(a)shall not be construed— as an admission that any product that is the subject of such notification violates any provision of this Act; or as evidence of the entity’s intent to market the product for an indication or use for which the product has not been approved or cleared by the Secretary. In the event of, or in advance of, a declaration of a public health emergency pursuant to section 319 of the Public Health Service Act, the Secretary shall designate and make publicly available, including on the public website of the Food and Drug Administration, a list of devices that are critical to preventing, screening, diagnosing, treating, or mitigating the spread of a disease or condition during such emergency. In developing such list, the Secretary shall take into consideration— the medical necessity of devices; the urgency to prevent serious injury or death; and the availability of other devices. During the course of such public health emergency, the Secretary shall update the list of essential devices as necessary, including adding and removing devices. For purposes of this section: The term essential device means a device designated in a list in effect under subsection (g). The term manufacturer means the entity that holds the medical device marketing submission, or if a medical device marketing submission is not required, the entity responsible for listing the medical device under section 510. The term meaningful disruption — means a change in production that is reasonably likely to lead to a reduction in the supply of an essential device that is more than negligible and affects the ability to fill orders or meet expected demand for the device of the manufacturer or contract terminal sterilizer involved; and does not include, so long as the manufacturer expects to resume operations in a short period of time, not to exceed 6 months, interruptions in— manufacturing due to matters such as routine maintenance or insignificant changes; or manufacturing of components or raw materials. 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 or a comparable device of that manufacturer or another manufacturer, including as a result of discontinuance of a device or an interruption in the manufacturing or importation of a device or a component of a device or the device constituent of a combination product. .
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Sec. 70531
Shortages of essential devices
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