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21 U.S.C. § 356j — Discontinuance or interruption in the production of medical devices
Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** 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;
shall, during, or in advance of, a public health emergency declared by the Secretary under [section 247d of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d&num=0&edition=prelim), notify the Secretary, in accordance with subsection (b), of a permanent discontinuance in the manufacture of the device (except for discontinuances 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.
**(b) Timing** 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) Distribution**
(1) **Public availability** — 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 sub
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Stable record: federal_law:legal_authorities:record_usc_10938d915881f918e9d8898d
Source file: Laws/federal/codes/united-states-code/title-21/section-356j-discontinuance-or-interruption-in-the-production-of-medical-devices--078dc97267.md
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Source location: Title 21, Chapter 9, § 356j; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) In general** 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;
shall, during, or in advance of, a public health emergency declared by the Secretary under [section 247d of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d&num=0&edition=prelim), notify the Secretary, in accordance with subsection (b), of a permanent discontinuance in the manufacture of the device (except for discontinuances 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.
**(b) Timing** 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) Distribution**
(1) **Public availability** — 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) **Public health exception** — 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) Confidentiality** 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552/b/4&num=0&edition=prelim) or [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim).
**(e) Failure to meet requirements** 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) Expedited inspections and reviews** 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/f/2&num=0&edition=prelim), 360e of this title, review of a notification under [section 360(k) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360/k&num=0&edition=prelim), 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) Device shortage list**
(1) **Establishment** — 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) **Contents** — 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) **Public availability**
(A) *In general* — Subject to subparagraphs (B) and (C), the Secretary shall make the information in the list under paragraph (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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim) or [section 552(b)(4) of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552/b/4&num=0&edition=prelim).
(C) *Public health exception* — 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) Additional notifications** 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) Rule of construction** 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e&num=0&edition=prelim), [section 360e–3 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e-3&num=0&edition=prelim) relating to the priority review program for devices, and [section 360bbb–3 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb-3&num=0&edition=prelim) 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 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) **Shortage** — 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.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) General requirement** A class III device—
(1) which is subject to an order issued under subsection (b) (or a regulation promulgated under such subsection prior to July 9, 2012); or
(2) which is a class III device because of [section 360c(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/f&num=0&edition=prelim),
is required to have, unless exempt under [section 360j(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/g&num=0&edition=prelim), an approval under this section of an application for premarket approval or, as applicable, an approval under subsection (c)(2) of a report seeking premarket approval.
**(b) Order to require premarket approval**
(1) In the case of a class III device which—
(A) was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976; or
(B) is (i) of a type so introduced or delivered, and (ii) is substantially equivalent to another device within that type,
the Secretary shall by administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in [section 360c(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/b&num=0&edition=prelim), and consideration of comments from all affected stakeholders, including patients, payors, and providers, notwithstanding subchapter II of chapter 5 of title 5, require that such device have an approval under this section of an application for premarket approval. Authority to issue such administrative order shall not be delegated below the Director of the Center for Devices and Radiological Health, acting in consultation with the
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360e
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Federal law — U.S. Code and appendices · legal_authorities
Whoever, being an officer or employee of the United States or of any department or agency thereof, any person acting on behalf of the Federal Housing Finance Agency, or agent of the Department of Justice as defined in the Antitrust Civil Process Act ([15 U.S.C. 1311–131](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1311–131&num=0&edition=prelim)4), or being an employee of a private sector organization who is or was assigned to an agency under chapter 37 of title 5, publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties or by reason of any examination or investigation made by, or return, report or record made to or filed with, such department or agency or officer or employee thereof, which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof to be seen or examined by any person except as provided by law; shall be fined under this title, or imprisoned not more than one year, or both; and shall be removed from office or employment.
Source: Supplied U.S. Code snapshot — release unconfirmed · 18 U.S.C. § 1905
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Emergencies** If the Secretary determines, after consultation with such public health officials as may be necessary, that—
(1) a disease or disorder presents a public health emergency; or
(2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists,
the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2). Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination.
**(b) Public Health Emergency Fund**
(1) **In general** — There is established in the Treasury a fund to be designated as the “Public Health Emergency Fund” to be made available to the Secretary without fiscal year limitation to carry out subsection (a) only if a public health emergency has been declared by the Secretary under such subsection or if the Secretary determines there is the significant potential for a public health emergency, to allow the Se
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 247d
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Federal law — U.S. Code and appendices · legal_authorities
Page 292
TITLE 21—FOOD AND DRUGS
§ 356j
1 So in original. Probably should be ‘‘a’’.
Subsec. (c). Pub. L. 117–328, § 3201(b), amended subsec.
(c) generally. Prior to amendment, subsec. (c) related
to an additional one-time report to be done within 180
days of Aug. 18, 2017.
Subsec. (d). Pub. L. 117–328, § 3201(c)(1), added subsec.
(d) and struck out former subsec. (d). Prior to amend-
ment, text read as follows: ‘‘If a holder of an approved
application fails to submit the information required
under subsection (a), (b), or (c), the Secretary may
move the application holder’s drugs from the active
section
of
the
list
published
under
subsection
355(j)(7)(A) of this title to the discontinued section of
the list, except that the Secretary shall remove from
the list in accordance with subsection 355(j)(7)(C) of
this title drugs the Secretary determines have been
withdrawn from sale for reasons of safety of effective-
ness.’’
Subsec. (e). Pub. L. 117–328, § 3201(d), substituted ‘‘sec-
tion 355(j)(7)(A) of this title’’ for ‘‘subsection 355(j)(7)(A)
of this title’’ and ‘‘section 355(j)(7)(C) of this title’’ for
‘‘subsection 355(j)(7)(C) of this title’’.
Pub. L. 117–328, § 3201(c)(2), inserted ‘‘The Secretary
shall
update
the
list
published
under
section
262(k)(9)(A) of title 42 based on information provided
under subsections (a), (b), and (c) by identifying as dis-
continued biological products that are not available for
sale, except that biological products for which the li-
cense has been revoked or suspended for safety, purity,
or potency reasons shall be removed from the list in ac-
cordance with section 262(k)(9)(B) of title 42.’’ before
‘‘The Secretary shall make monthly updates’’ and sub-
stituted ‘‘monthly updates to the lists referred
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 356j
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.