PREVENTING MEDICAL DEVICE SHORTAGES.

SEC. 2514. PREVENTING MEDICAL DEVICE SHORTAGES.(a) Notifications.—Section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j) is amended—(1) in subsection (f), by inserting “or (h)” after “subsection (a)”; (2) by redesignating subsections (h) and (i) as subsections (i) and (j), respectively; and (3) by inserting after subsection (g) the following:“(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 136 STAT. 5806 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) Guidance on Voluntary Notifications of Discontinuance or Interruption of Device Manufacture.—Not later than 1 year after the date of enactment of this Act, the Secretary shall issue draft guidance to facilitate voluntary notifications under subsection (h) of section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j), as added by subsection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 The Secretary shall issue final guidance not later than 1 year after the close of the comment period for the draft guidance. (c) Guidance on Device Shortage Notification Requirement.—Not later than 1 year after the date of enactment of this Act, the Secretary shall issue or revise draft guidance regarding requirements under section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j).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.