PREVENT Medical Device Shortages Act of 2022

To improve the program for reporting on device shortages. 1. Short title This Act may be cited as the Planning, Reporting, and Enabling Voluntary Expansion of Notifications Targeting Medical Device Shortages Act of 2022 PREVENT Medical Device Shortages Act of 2022 2. Preventing medical device shortages (a) Notifications (1) In general Section 506J of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356j (A) in the flush text at the end of subsection (a), by inserting or of any other circumstance that is likely to lead to a meaningful disruption in the supply of the device or a shortage of the device and other devices that could reasonably be substituted for that device in the United States (B) in subsection (f), by inserting or (h) subsection (a) (C) by redesignating subsections (h) and (i) as subsections (j) and (k), respectively; and (D) by inserting after subsection (g) the following: (h) Additional notifications The Secretary may receive 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) Risk management plans Each manufacturer of a device that is critical to the public health, including devices that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery, shall develop, maintain, and, as appropriate, implement a redundancy risk management plan that identifies and evaluates risks to the supply of the device, as applicable, for each establishment in which such device is manufactured. A risk management plan under this subsection— (1) may identify and evaluate risks to the supply of more than 1 device manufactured at the same establishment; and (2) shall be subject to inspection and copying, both remotely and physically, by the Secretary pursuant to section 704 or at the request of the Secretary. . (2) Report Not later than 1 year after the date of enactment of this Act, and annually for 4 years thereafter, the Secretary of Health and Human Services (referred to in this section as the Secretary 21 U.S.C. 356j (3) 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

Summary: Planning, Reporting, and Enabling Voluntary Expansion of Notifications Targeting Medical Device Shortages Act of 2022 or the PREVENT Medical Device Shortages Act of 2022 This bill expands existing requirements for manufacturers of certain medical devices to alert the Food and Drug Administration (FDA) of supply disruptions and addresses related issues. Under this bill, a manufacturer of a medical device that is critical to public health during a declared public health emergency must notify the FDA as soon as practicable of any circumstance that is likely to lead to a meaningful disruption to the supply of the device in the United States. Currently, the manufacturer is only required to notify the FDA of supply disruptions stemming from manufacturing issues. The bill also authorizes the FDA to receive notifications from manufacturers of medical devices that are critical to public health about manufacturing issues that are likely to lead to a meaningful disruption to the U.S. supply of the device. Each manufacturer of a medical device that is critical to the public health must develop and implement a redundancy risk management plan in each manufacturing facility for the device. Such a plan shall be subject to FDA inspection.