---
kind: "section"
citation: "21 U.S.C. § 356j"
title: "21"
title_heading: "Food and Drugs"
number: "356j"
heading: "Discontinuance or interruption in the production of medical devices"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/356j"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

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

- (a) **In general—** A [manufacturer](/usc/21/360hh.md?p=3) of a [device](/usc/21/321.md?p=h-1) that—
  - (1) is critical to public health during a public health emergency, including [devices](/usc/21/321.md?p=h-1) that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery; or
  - (2) for which the [Secretary](/usc/21/321.md?p=d) determines that information on potential meaningful supply disruptions of such [device](/usc/21/321.md?p=h-1) is needed during, or in advance of, a public health emergency;

  shall, during, or in advance of, a public health emergency declared by the [Secretary](/usc/21/321.md?p=d) under [section 247d of title 42](/usc/42/247d.md), notify the [Secretary](/usc/21/321.md?p=d), in accordance with [subsection (b)](#b), of a permanent discontinuance in the manufacture of the [device](/usc/21/321.md?p=h-1) (except for discontinuances as a result of an approved modification of the [device](/usc/21/321.md?p=h-1)) or an interruption of the manufacture of the [device](/usc/21/321.md?p=h-1) that is likely to lead to a meaningful disruption in the supply of that [device](/usc/21/321.md?p=h-1) in the United States, and the reasons for such discontinuance or interruption.

- (b) **Timing—** A notice required under [subsection (a)](#a) shall be submitted to the [Secretary](/usc/21/321.md?p=d)—
  - (1) at least 6 months prior to the date of the discontinuance or interruption; or
  - (2) if compliance with [paragraph (1)](#b-1) is not possible, as soon as practicable.
- (c) **Distribution—**
  - (1) **Public availability—** To the maximum extent practicable, subject to [paragraph (2)](#c-2), the [Secretary](/usc/21/321.md?p=d) shall [distribute](/usc/21/360eee.md?p=5), through such means as the [Secretary](/usc/21/321.md?p=d) determines appropriate, information on the discontinuance or interruption of the manufacture of [devices](/usc/21/321.md?p=h-1) reported under [subsection (a)](#a) to appropriate organizations, including physician, health provider, patient organizations, and supply chain partners, as appropriate and applicable, as described in [subsection (g)](#g).
  - (2) **Public health exception—** The [Secretary](/usc/21/321.md?p=d) may choose not to make information collected under this section publicly available pursuant to this section if the [Secretary](/usc/21/321.md?p=d) determines that disclosure of such information would adversely affect the public health, such as by increasing the possibility of unnecessary over purchase of [product](/usc/21/360eee.md?p=13), component parts, or other disruption of the availability of medical [products](/usc/21/360eee.md?p=13) to patients.
- (d) **Confidentiality—** Nothing in this section shall be construed as authorizing the [Secretary](/usc/21/321.md?p=d) to disclose any information that is a trade secret or confidential information subject to [section 552(b)(4) of title 5](/usc/5/552.md?p=b-4) or [section 1905 of title 18](/usc/18/1905.md).
- (e) **Failure to meet requirements—** If a [person](/usc/21/321.md?p=e) fails to submit information required under [subsection (a)](#a) in accordance with [subsection (b)](#b)—
  - (1) the [Secretary](/usc/21/321.md?p=d) shall issue a letter to such [person](/usc/21/321.md?p=e) informing such [person](/usc/21/321.md?p=e) of such failure;
  - (2) not later than 30 calendar days after the issuance of a letter under [paragraph (1)](#e-1), the [person](/usc/21/321.md?p=e) who receives such letter shall submit to the [Secretary](/usc/21/321.md?p=d) a written response to such letter setting forth the basis for noncompliance and providing information required under [subsection (a)](#a); and
  - (3) not later than 45 calendar days after the issuance of a letter under [paragraph (1)](#e-1), the [Secretary](/usc/21/321.md?p=d) shall make such letter and any response to such letter under [paragraph (2)](#e-2) available to the public on the internet website of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, with appropriate redactions made to protect information described in [subsection (d)](#d), except that, if the [Secretary](/usc/21/321.md?p=d) determines that the letter under [paragraph (1)](#e-1) was issued in error or, after review of such response, the [person](/usc/21/321.md?p=e) had a reasonable basis for not notifying as required under [subsection (a)](#a), the requirements of this paragraph shall not apply.
- (f) **Expedited inspections and reviews—** If, based on notifications described in subsection [(a)](#a) or [(h)](#h) or any other relevant information, the [Secretary](/usc/21/321.md?p=d) concludes that there is, or is likely to be, a shortage of an[^1] [device](/usc/21/321.md?p=h-1), the [Secretary](/usc/21/321.md?p=d) shall, as appropriate—
  - (1) prioritize and expedite the review of a submission under [section 360c(f)(2) of this title](/usc/21/360c.md?p=f-2), [360e](/usc/21/360e.md) of this title, review of a notification under [section 360(k) of this title](/usc/21/360.md?p=k), or [360j(m)](/usc/21/360j.md?p=m) of this title for a [device](/usc/21/321.md?p=h-1) 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) **Device shortage list—**
  - (1) **Establishment—** The [Secretary](/usc/21/321.md?p=d) shall establish and maintain an up-to-date list of [devices](/usc/21/321.md?p=h-1) that are determined by the [Secretary](/usc/21/321.md?p=d) to be in shortage in the United States.
  - (2) **Contents—** For each [device](/usc/21/321.md?p=h-1) included on the list under [paragraph (1)](#g-1), the [Secretary](/usc/21/321.md?p=d) shall include the following information:
    - (A) The category or name of the [device](/usc/21/321.md?p=h-1) in shortage.
    - (B) The name of each [manufacturer](/usc/21/360hh.md?p=3) of such [device](/usc/21/321.md?p=h-1).
    - (C) The reason for the shortage, as determined by the [Secretary](/usc/21/321.md?p=d), 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](/usc/21/321.md?p=h-1).
      - (v) Delay in shipping of the [device](/usc/21/321.md?p=h-1).
      - (vi) Delay in sterilization of the [device](/usc/21/321.md?p=h-1).
      - (vii) Demand increase for the [device](/usc/21/321.md?p=h-1).
      - (viii) Facility closure.
    - (D) The estimated duration of the shortage as determined by the [Secretary](/usc/21/321.md?p=d).
  - (3) **Public availability—**
    - (A) **In general—** Subject to subparagraphs [(B)](#g-3-B) and [(C)](#g-3-C), the [Secretary](/usc/21/321.md?p=d) shall make the information in the list under [paragraph (1)](#g-1) publicly available.
    - (B) **Trade secrets and confidential information—** Nothing in this subsection shall be construed to alter or amend [section 1905 of title 18](/usc/18/1905.md) or [section 552(b)(4) of title 5](/usc/5/552.md?p=b-4).
    - (C) **Public health exception—** The [Secretary](/usc/21/321.md?p=d) may elect not to make information collected under this subsection publicly available if the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=h-1) to patients).
- (h) **Additional notifications—** The [Secretary](/usc/21/321.md?p=d) may receive voluntary notifications from a [manufacturer](/usc/21/360hh.md?p=3) of a [device](/usc/21/321.md?p=h-1) that is life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery, or any other [device](/usc/21/321.md?p=h-1) the [Secretary](/usc/21/321.md?p=d) determines to be critical to the public health, pertaining to a permanent discontinuance in the manufacture of the [device](/usc/21/321.md?p=h-1) (except for any discontinuance as a result of an approved modification of the [device](/usc/21/321.md?p=h-1)) or an interruption of the manufacture of the [device](/usc/21/321.md?p=h-1) that is likely to lead to a meaningful disruption in the supply of that [device](/usc/21/321.md?p=h-1) in the United States, and the reasons for such discontinuance or interruption.
- (i) **Rule of construction—** Nothing in this section shall be construed to affect the authority of the [Secretary](/usc/21/321.md?p=d) on March 27, 2020, to expedite the review of [devices](/usc/21/321.md?p=h-1) under [section 360e of this title](/usc/21/360e.md), [section 360e–3 of this title](/usc/21/360e–3.md) relating to the priority review program for [devices](/usc/21/321.md?p=h-1), and [section 360bbb–3 of this title](/usc/21/360bbb–3.md) relating to the emergency use authorization authorities.
- (j) **Definitions—** In this section:
  - (1) **Meaningful disruption—** 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](/usc/21/321.md?p=h-1) by a [manufacturer](/usc/21/360hh.md?p=3) that is more than negligible and affects the ability of the [manufacturer](/usc/21/360hh.md?p=3) to fill orders or meet expected demand for its [product](/usc/21/360eee.md?p=13);
    - (B) does not include interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the [manufacturer](/usc/21/360hh.md?p=3) 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](/usc/21/321.md?p=h-1) and the [manufacturer](/usc/21/360hh.md?p=3) 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](/usc/21/321.md?p=h-1) designed to perform more than one procedure or diagnostic test.
  - (2) **Shortage—** The term “shortage”, with respect to a [device](/usc/21/321.md?p=h-1), means a period of time when the demand or projected demand for the [device](/usc/21/321.md?p=h-1) within the United States exceeds the supply of the [device](/usc/21/321.md?p=h-1).

## Footnotes

[^1]: So in original. Probably should be “a”.

## Source credit

(June 25, 1938, ch. 675, § 506J, as added Pub. L. 116–136, div. A, title III, § 3121, Mar. 27, 2020, 134 Stat. 363; amended Pub. L. 117–328, div. FF, title II, § 2514(a), Dec. 29, 2022, 136 Stat. 5805.)

## Notes

### 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.”