DEVICE Act of 2025

HR 2372, the DEVICE Act of 2025, requires medical device manufacturers to notify the FDA before changing device designs or reprocessing instructions for devices sold across state lines. It also mandates that manufacturers report within 5 days any communications about device changes (like design, reprocessing, or safety concerns) sent to foreign healthcare providers. The bill defines "rapid assessment tests" for verifying proper reprocessing of reusable medical devices and requires manufacturers to provide validated instructions and data for these tests. This affects all manufacturers of reusable medical devices marketed in interstate commerce.