The DEVICE Act of 2025 strengthens FDA oversight of medical devices by requiring manufacturers to report certain changes and communications to the Food and Drug Administration. Specifically, manufacturers must notify the FDA in writing before making changes to a device's design or reprocessing instructions, and must report within five days any communications about design changes, reprocessing updates, or safety concerns that are widely shared with foreign healthcare providers. The bill also creates a new category of devices called "rapid assessment tests" designed to verify that reusable medical devices are properly cleaned and sterilized, and requires the FDA to develop regulations within one year establishing which of these tests must include validated instructions for use and supporting data before FDA clearance. The legislation applies to all manufacturers of medical devices sold in interstate commerce and aims to improve the safety and efficacy of medical devices by ensuring better communication about critical changes and proper device reprocessing standards.
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