§356j — Title 21 Food and Drugs | U.S. Code

Summary

Manufacturers of certain important medical devices — like life‑supporting or surgery‑use devices, or any device the Secretary says is critical — must tell the Secretary if they plan to stop making the device or expect a big interruption in production. The notice must come at least 6 months before the stop or interruption, or as soon as possible if 6 months isn’t realistic. The Secretary will share reported problems with doctors, hospitals, patient groups, and supply partners when useful, but can keep information private if releasing it would hurt public health (for example, by causing hoarding). Trade secrets and other protected business information are not disclosed. If a maker fails to notify, the Secretary will send a letter; the maker has 30 calendar days to explain and provide the needed information, and the Secretary will post the letter and response on the FDA website within 45 calendar days unless the Secretary finds the notice was wrong or the maker had a reasonable reason not to tell. If a shortage is likely, the Secretary can speed up reviews of device applications and inspections. The Secretary will keep a current public list of devices in shortage and, for each, report the device name or category, makers, reason for the shortage (from a set list like manufacturing problems, parts shortages, demand increases, or facility closure), and an estimated duration, unless posting would harm public health. Meaningful disruption: a production change likely to cut supply more than a tiny amount and affect the maker’s ability to fill orders, excluding short routine outages (expected to end within 6 months) and some component delays that don’t cause shortages. Shortage: when U.S. demand or expected demand is greater than the available supply.

Title 21, §356j

Food and Drugs — Source: USLM XML via OLRC

(a)A manufacturer of a device that—

(1)is critical to public health during a public health emergency, including devices that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery; or

(2)for which the Secretary determines that information on potential meaningful supply disruptions of such device is needed during, or in advance of, a public health emergency;

(b)A notice required under subsection (a) shall be submitted to the Secretary—

(1)at least 6 months prior to the date of the discontinuance or interruption; or

(2)if compliance with paragraph (1) is not possible, as soon as practicable.

(c)(1)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).

(2)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.

(d)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.

(e)If a person fails to submit information required under subsection (a) in accordance with subsection (b)—

(1)the Secretary shall issue a letter to such person informing such person of such failure;

(2)not later than 30 calendar days after 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

(3)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 internet website of the Food and Drug Administration, with appropriate redactions made to protect information described in subsection (d), 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.

(f)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—

(1)prioritize and expedite the review of a submission under section 360c(f)(2) of this title, 360e of this title, review of a notification under section 360(k) of this title, or 360j(m) of this title for a device that could help mitigate or prevent such shortage; or

(2)prioritize and expedite an inspection or reinspection of an establishment that could help mitigate or prevent such shortage.

(g)(1)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.

(2)For each device included on the list under paragraph (1), the Secretary shall include the following information:

(A)The category or name of the device in shortage.

(B)The name of each manufacturer of such device.

(C)The reason for the shortage, as determined by the Secretary, selecting from the following categories:

(i)Requirements related to complying with good manufacturing practices.

(ii)Regulatory delay.

(iii)Shortage or discontinuance of a component or part.

(iv)Discontinuance of the manufacture of the device.

(v)Delay in shipping of the device.

(vi)Delay in sterilization of the device.

(vii)Demand increase for the device.

(viii)Facility closure.

(D)The estimated duration of the shortage as determined by the Secretary.

(3)(A)Subject to subparagraphs (B) and (C), the Secretary shall make the information in the list under paragraph (1) publicly available.

(B)Nothing in this subsection shall be construed to alter or amend section 1905 of title 18 or section 552(b)(4) of title 5.

(C)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).

(h)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.

(i)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.

(j)In this section:

(1)The term “meaningful disruption”—

(A)means a change in production that is reasonably likely to lead to a reduction in the supply of a device by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product;

(B)does not include interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time, not to exceed 6 months;

(C)does not include interruptions in manufacturing of components or raw materials so long as such interruptions do not result in a shortage of the device and the manufacturer expects to resume operations in a reasonable period of time; and

(D)does not include interruptions in manufacturing that do not lead to a reduction in procedures or diagnostic tests associated with a medical device designed to perform more than one procedure or diagnostic test.

(2)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.

Notes & Related Subsidiaries

Editorial Notes

Amendments

2022—Subsec. (f). Pub. L. 117–328, § 2514(a)(1), inserted “or (h)” after “subsection (a)” in introductory provisions. Subsecs. (h) to (j). Pub. L. 117–328, § 2514(a)(2), (3), added subsec. (h) and redesignated former subsecs. (h) and (i) as (i) and (j), respectively.

Statutory Notes and Related Subsidiaries

Guidance on Voluntary Notifications of Discontinuance or Interruption of Device Manufacture Pub. L. 117–328, div. FF, title II, § 2514(b), Dec. 29, 2022, 136 Stat. 5806, provided that: “Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Secretary shall issue draft guidance to facilitate voluntary notifications under subsection (h) of section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j), as added by subsection (a). Such guidance shall include a description of circumstances in which a voluntary notification under such subsection (h) may be appropriate, recommended timeframes for such a notification, the process for receiving such a notification, and actions the Secretary may take to mitigate or prevent a shortage resulting from a discontinuance or interruption in the manufacture of a device for which such notification is received. The Secretary shall issue final guidance not later than 1 year after the close of the comment period for the draft guidance.” Guidance on Device Shortage Notification Requirement Pub. L. 117–328, div. FF, title II, § 2514(c), Dec. 29, 2022, 136 Stat. 5806, provided that: “Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Secretary shall issue or revise draft guidance regarding requirements under section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j). Such guidance shall include a list of each device product code for which a manufacturer of such device is required to notify the Secretary in accordance with section 506J.”

§356j Discontinuance or interruption in the production of medical devices