DEVICE Act of 2025

This bill tightens safety rules for medical devices. It makes companies tell the federal health regulator in writing before they change a device’s design or its cleaning/reprocessing instructions for use in the United States. If a company doesn’t follow these reporting rules, its devices can be treated as out of compliance under federal law . It also requires companies to alert the regulator within 5 days if they send widely shared messages to health care providers in other countries about design changes, cleaning protocol changes, or safety concerns; this applies to messages from the company or its affiliates.

The bill also addresses “rapid assessment tests” used to check whether a device has been cleaned properly. Within 1 year, the regulator must publish a list of test types that will need validated instructions for use and supporting validation data when companies seek clearance. After that list comes out, clearance requests for those tests will not be accepted unless they include that information.

• Who is affected: Medical device makers that sell products in the U.S..
• What changes:
  • Written notice is required before changing device design or cleaning instructions.
  • Notify the regulator within 5 days after widely sharing certain safety or change notices with foreign health providers; includes affiliate communications.
  • For rapid cleaning-check tests, a new list will set which ones must include validated instructions and data to get cleared; otherwise, requests won’t be accepted once the list is published.
• When:
  • The rapid-test list is due within 1 year of the law taking effect; enforcement for those tests starts when the initial list is published.