The U.S. Food and Drug Administration (FDA) is providing a device shortage list as part of the implementation of section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The device shortage list reflects the categories of devices that the FDA has determined to be in shortage at this time and will be updated as the COVID-19 pandemic evolves. In addition, the FDA is providing a list of medical devices for which the FDA has been notified that manufacturing has been permanently discontinued.
Under section 506J, manufacturers of certain devices must notify the FDA of an interruption or permanent discontinuance in manufacturing. The publication of these lists allows for transparency to the public and stakeholders about devices that the FDA has determined to be in shortage at this time, or for which the Agency has been notified that manufacturing has been permanently discontinued.
