Bill > S3477

This bill, the PREVENT Medical Device Shortages Act of 2022, aims to improve the program for reporting on medical device shortages. The key provisions of the bill include: 1. Expanding the notification requirements for manufacturers of critical medical devices, such as life-supporting, life-sustaining, or emergency-use devices, to report not only permanent discontinuations but also any circumstances that are likely to lead to a meaningful disruption in the supply of the device. 2. Requiring manufacturers of critical medical devices to develop and maintain redundancy risk management plans to identify and evaluate risks to the supply of their devices. 3. Requiring the Secretary of Health and Human Services to prepare and submit annual reports to Congress on the use of the device shortage notification information provided by manufacturers. 4. Directing the Secretary to issue guidance to facilitate voluntary notifications from manufacturers about discontinuances or interruptions in the manufacture of critical medical devices, including recommendations on timeframes, the process for receiving such notifications, and actions the Secretary may take to mitigate or prevent resulting shortages.

Health and Social Services

https://www.congress.gov/bill/117th-congress/senate-bill/3477/all-info