DEVICE Act of 2025

The DEVICE Act of 2025 introduces new reporting requirements for medical device manufacturers under the Federal Food, Drug, and Cosmetic Act. Manufacturers must provide written notice to the Secretary before implementing any changes to a device's design or its reprocessing instructions. Failure to comply with these reporting mandates would render the device adulterated. Additionally, the bill requires manufacturers to report within five calendar days any widely disseminated communications to foreign healthcare providers concerning device design changes, reprocessing protocols, or safety concerns. It also expands the definition of a medical device to include rapid assessment tests specifically designed to ensure the proper reprocessing of reusable devices. The Secretary is tasked with creating a list of these tests, for which premarket notifications must include validated instructions for use and specific validation data to ensure their effectiveness and safety.