21 U.S.C. § 356j — Discontinuance or interruption in the production 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 used in emergency medical care or surgery — or (2) is one the Secretary determines needs supply-disruption reporting during or ahead of a public health emergency, must, during or in advance of a declared emergency, notify the Secretary of a permanent discontinuance in making the device (except discontinuances from an approved device modification), or an interruption likely to cause a meaningful disruption in U.S. supply, and the reasons for it. (b) Timing. Notice must be submitted at least 6 months before the discontinuance or interruption, or if that's not possible, as soon as practicable. (c) Distribution. To the maximum extent practicable, subject to a public health exception, the Secretary must distribute information on reported discontinuances or interruptions to appropriate organizations, including physician, health provider, and patient organizations, and supply chain partners, as described in subsection (g). The Secretary may choose not to release information under this section if disclosure would adversely affect public health, such as by encouraging unnecessary over-purchasing or otherwise disrupting the availability of medical products to patients. (d) Confidentiality. Nothing in this section authorizes the Secretary to disclose trade secrets or confidential information protected under section 552(b)(4) of title 5 or section 1905 of title 18. (e) Failure to meet requirements. If a person fails to submit required information on time, the Secretary must send a letter about the failure. Within 30 calendar days, the person must submit a written response explaining the noncompliance and providing the missing information. Within 45 calendar days, the Secretary must make the letter and response public online, with redactions to protect confidential information — unless the Secretary determines the letter was issued in error, or after review decides the person had a reasonable basis for not notifying. (f) Expedited inspections and reviews. If, based on notifications or other relevant information, the Secretary concludes there is or is likely to be a device shortage, the Secretary must, as appropriate: prioritize and expedite review of certain device submissions or notifications (under sections 360c(f)(2), 360e, 360(k), or 360j(m)) that could help mitigate or prevent the shortage; or prioritize and expedite an inspection or reinspection that could help. (g) Device shortage list. The Secretary must establish and maintain an up-to-date list of devices determined to be in shortage in the United States. For each listed device, the Secretary must include: the device's category or name; the name of each manufacturer; the reason for the shortage, chosen from categories including good-manufacturing-practice compliance issues, regulatory delay, shortage or discontinuance of a component, discontinued manufacture, shipping delay, sterilization delay, demand increase, or facility closure; and the shortage's estimated duration. The Secretary must generally make this list information public, subject to trade-secret and confidential-information protections, and subject to a public health exception letting the Secretary withhold information whose disclosure would adversely affect public health, such as by increasing the risk of hoarding. (h) Additional notifications. The Secretary may accept voluntary notifications from a manufacturer of a device that is life-supporting, life-sustaining, used in emergency care or surgery, or otherwise deemed critical to public health, about a permanent discontinuance (except from an approved modification) or an interruption likely to cause a meaningful supply disruption, and the reasons for it. (i) Rule of construction. Nothing in this section affects the Secretary's authority, as it existed on March 27, 2020, to expedite device review under section 360e, the device priority review program under section 360e–3, or emergency use authorizations under section 360bbb–3. (j) Definitions. "Meaningful disruption" means a production change reasonably likely to cause a more-than-negligible reduction in a manufacturer's device supply, affecting its ability to fill orders or meet expected demand — but excludes interruptions from routine maintenance or insignificant changes if operations resume within 6 months; interruptions in making components or raw materials that don't cause a device shortage and are expected to resume within a reasonable time; and interruptions that don't reduce the procedures or tests available from a multi-use device. "Shortage" means a period when U.S. demand or projected demand for a device exceeds its supply.