21 U.S.C. § 356j — Discontinuance or interruption in the pro-

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remove from the list in accordance with subsection 355(j)(7)(C) of this title drugs the Secretary determines have been withdrawn from sale for reasons of safety of effective- ness.’’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biological products that are not available for sale, except that biological products for which the li- cense has been revoked or suspended for safety, purity, or potency reasons shall be removed from the list in ac- cordance with section 262(k)(9)(B) of title 42.’’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 to in the preceding sentences’’ for ‘‘monthly updates to the list’’ and ‘‘and shall update such lists based on’’ for ‘‘and shall update the list based on’’. § 356j. Discontinuance or interruption in the pro- duction of medical devices (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 sur- gery; 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 sec- tion 247d of title 42, notify the Secretary, in ac- cordance with subsection (b), of a permanent discontinuance in the manufacture of the device (except for discontinuances as a result of an ap- proved modification of the device) or an inter- ruption 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 interrup- tion. (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 dis- tribute, through such means as the Secretary determines appropriate, information on the discontinuance or interruption of the manu- facture of devices reported under subsection (a) to appropriate organizations, including physician, health provider, patient organiza- tions, and supply chain partners, as appro- priate and applicable, as described in sub- section (g). (2) Public health exception The Secretary may choose not to make in- formation collected under this section pub- licly 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, compo- nent parts, or other disruption of the avail- ability of medical products to patients. (d) Confidentiality Nothing in this section shall be construed as authorizing the Secretary to disclose any infor- mation that is a trade secret or confidential in- formation subject to section 552(b)(4) of title 5 or section 1905 of title 18. (e) Failure to meet requirements If a person fails to submit information re- quired 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 noncompli- ance 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 re- sponse to such letter under paragraph (2) available to the public on the internet website of the Food and Drug Administration, with ap- propriate redactions made to protect informa- tion described in subsection (d), except that, if the Secretary determines that the letter under paragraph (1) was issued in error or, after re- view of such response, the person had a reason- able basis for not notifying as required under subsection (a), the requirements of this para- graph shall not apply. (f) Expedited inspections and reviews If, based on notifications described in sub- section (a) or (h) or any other relevant informa- tion, the Secretary concludes that there is, or is likely to be, a shortage of an 1 device, the Sec- retary 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. Page 293 TITLE 21—FOOD AND DRUGS § 356j (g) Device shortage list (1) Establishment The Secretary shall establish and maintain an up-to-date list of devices that are deter- mined 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 deter- mined 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 informa- tion Nothing in this subsection shall be con- strued to alter or amend section 1905 of title 18 or section 552(b)(4) of title 5. (C) Public health exception The Secretary may elect not to make in- formation collected under this subsection publicly available if the Secretary deter- mines that disclosure of such information would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the avail- ability of the device to patients). (h) Additional notifications The Secretary may receive voluntary notifica- tions from a manufacturer of a device that is life-supporting, life-sustaining, or intended for use in emergency medical care or during sur- gery, or any other device the Secretary deter- mines to be critical to the public health, per- taining to a permanent discontinuance in the manufacture of the device (except for any dis- continuance as a result of an approved modifica- tion 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, section 360e–3 of this title relating to the priority review program for devices, and section 360bbb–3 of this title relat- ing to the emergency use authorization authori- ties. (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 man- ufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short pe- riod of time, not to exceed 6 months; (C) does not include interruptions in man- ufacturing of components or raw materials so long as such interruptions do not result in a shortage of the device and the manufac- turer expects to resume operations in a rea- sonable period of time; and (D) does not include interruptions in man- ufacturing 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 de- vice, means a period of time when the demand or projected demand for the device within the United States exceeds the supply of the device. (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.) Editorial Notes AMENDMENTS 2022—Subsec. (f). Pub. L. 117–328, § 2514(a)(1), inserted ‘‘or (h)’’ after ‘‘subsection (a)’’ in introductory provi- sions. 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 DIS- CONTINUANCE OR INTERRUPTION OF DEVICE MANUFAC- TURE 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 no- tification, the process for receiving such a notification, and actions the Secretary may take to mitigate or pre- vent a shortage resulting from a discontinuance or Page 294 TITLE 21—FOOD AND DRUGS § 356k 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 re- garding 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 re- quired to notify the Secretary in accordance with sec- tion 506J.’’ § 356k. Platform technologies (a) In general The Secretary shall establish a program for the designation of platform technologies that meet the criteria described in subsection (b). (b) Criteria A platform technology incorporated within or utilized by a drug or biological product is eligi- ble for designation as a designated platform technology under this section if— (1) the platform technology is incorporated in, or utilized by, a drug approved under sec- tion 355 of this title or a biological product li- censed under section 351 of the Public Health Service Act [42 U.S.C. 262]; (2) preliminary evidence submitted by the sponsor of the approved or licensed drug de- scribed in paragraph (1), or a sponsor that has been granted a right of reference to data sub- mitted in the application for such drug, dem- onstrates that the platform technology has the potential to be incorporated in, or utilized by, more than one drug without an adverse ef- fect on quality, manufacturing, or safety; and (3) data or information submitted by the ap- plicable person under paragraph (2) indicates that incorporation or utilization of the plat- form technology has a reasonable likelihood to bring significant efficiencies to the drug de- velopment or manufacturing process and to the review process. (c) Request for designation A person may request the Secretary designate a platform technology as a designated platform technology concurrently with, or at any time after, submission under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)] for the inves- tigation of a drug that incorporates or utilizes the platform technology that is the subject of the request. (d) Designation (1) In general Not later than 90 calendar days after the re- ceipt of a request under subsection (c), the Secretary shall determine whether the plat- form technology that is the subject of the re- quest meets the criteria described in sub- section (b). (2) Designation If the Secretary determines that the plat- form technology meets the criteria described in subsection (b), the Secretary shall des- ignate the platform technology as a des- ignated platform technology and may expedite the development and review of any subsequent application submitted under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for a drug that uses or incorporates the platform technology pursuant to subsection (e), as appropriate. (3) Determination not to designate If the Secretary determines that the plat- form technology does not meet the criteria under subsection (b), the Secretary shall in- clude with the determination not to designate the technology a written description of the ra- tionale for such determination. (4) Revocation of designation The Secretary may revoke a designation made under paragraph (2), if the Secretary de- termines that the designated platform tech- nology no longer meets the criteria described in subsection (b). The Secretary shall commu- nicate the determination to revoke a designa- tion to the requesting sponsor in writing, in- cluding a description of the rationale for such determination. (5) Applicability Nothing in this section shall prevent a prod- uct that uses or incorporates a designated platform technology from being eligible for expedited approval pathways if it is otherwise eligible under this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.]. (e) Actions The Secretary may take actions to expedite the development and review of an application for a drug that incorporates or utilizes a des- ignated platform technology, including— (1) engaging in early interactions with the sponsor to discuss the use of the designated platform technology and what is known about such technology, including data previously submitted that is relevant to establishing, as applicable, safety or efficacy under section 355(b) of this title or safety, purity, or potency under section 351(a) of the Public Health Serv- ice Act [42 U.S.C. 262(a)]; (2) providing timely advice to, and inter- active communication with, the sponsor re- garding the development of the drug that pro- poses to use the designated platform tech- nology to ensure that the development pro- gram designed to gather data necessary for ap- proval or licensure is as efficient as prac- ticable, which may include holding meetings with the sponsor and the review team through- out the development of the drug; and (3) considering inspectional findings, includ- ing prior findings, related to the manufacture of a drug that incorporates or utilizes the des- ignated platform technology. (f) Leveraging data from designated platform technologies The Secretary shall, consistent with applica- ble standards for approval, authorization, or li- censure under this chapter and section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)], allow the sponsor of an application under sec-