New DEVICE Act Mandates Pre-Approval Reporting for Medical Device Design Changes and Foreign Safety Alerts

The DEVICE Act of 2025 is a serious procedural upgrade for how medical device manufacturers interact with the FDA. Think of it as the agency installing a much tighter digital leash on companies that make everything from surgical tools to pacemakers. It’s all about getting advanced warning on design changes and making sure reusable tools are actually clean.

The New Rule for Tweaking Your Tech

If a medical device manufacturer wants to change a product’s design or alter the instructions for how that device should be reprocessed (that’s the industry term for cleaning and sterilizing it for reuse), they now have to give the FDA written notice before making the change. This is a big shift. Previously, some changes might have been handled after the fact, but Section 2 of this Act mandates pre-notification. Why does this matter to you? Because if a company skips this step, even if the physical change is minor, the device is automatically considered “adulterated” under federal law. That's a huge hammer the FDA can now wield, meaning a simple paperwork failure could lead to a product being pulled off the market or restricted. The penalty is severe, which should incentivize strict compliance, but it also creates a high-stakes administrative burden for manufacturers.

Five-Day Rule for Foreign Safety Alerts

Section 3 introduces a fascinating new transparency requirement regarding international communications. If a device manufacturer or its affiliate widely communicates with foreign health care providers about changes to a device’s design, updates to reprocessing protocols, or any safety concerns, they have just five calendar days to report that communication to the FDA. Essentially, if a company tells doctors in Germany about a critical flaw in a surgical robot, they must immediately tell the US regulator about that conversation. This provision closes a potential loophole where safety issues might be discussed overseas before being formally reported domestically. For patients, this means the FDA should have faster access to global safety intelligence, which is a clear win for oversight.

Cleaning Up the Cleaners: Validating Reprocessing Tests

Perhaps the most practical change for patient safety involves reusable medical equipment. Think of surgical instruments, endoscopes, or anything that gets cleaned and used again. Section 4 tackles the tools used to check if those devices are actually clean, known as “rapid assessment tests.” The Act formally defines these tests as medical devices themselves. This means the FDA will now regulate the tests used to verify sterilization.

Within one year of the Act passing, the FDA must publish a list of these rapid assessment tests that require specific validation data and detailed instructions for use. If a manufacturer is selling a test designed to confirm that a reusable device is clean, they now have to prove to the FDA that their test actually works and is accurate. For anyone who has ever worried about hospital-acquired infections, this is a significant step toward ensuring the tools used to verify cleanliness are themselves reliable. The goal is to eliminate guesswork and ensure that the instructions for use and the proof of accuracy are rigorously validated before these tests hit the market.