DEVICE Act Mandates Stricter Reporting for Medical Device Changes, Adds New Tests for Reusable Gear

The DEVICE Act of 2025 introduces new federal rules aimed at boosting the safety and transparency surrounding medical devices. It primarily requires manufacturers to report certain changes and communications regarding their devices to the Secretary of Health and Human Services (HHS) and establishes requirements for tests used to verify the cleaning of reusable medical equipment.

Keeping Tabs on Device Tweaks

Under this act, companies selling medical devices across state lines must notify HHS before making changes to a device's design or its recommended cleaning (reprocessing) instructions (Section 2). Skipping this notification step could lead to the device being classified as "adulterated," essentially meaning it can't be legally marketed. Additionally, if a manufacturer tells healthcare providers in another country about design changes, new cleaning protocols, or safety concerns related to a device, they have five calendar days to report that same communication to HHS (Section 3). This seems designed to ensure US regulators and providers aren't left behind if important safety information surfaces abroad first.

For example, if a company discovers a better way to sterilize a surgical scope it sells globally and informs European hospitals, it must also inform HHS within five days. Similarly, any design modification planned for a device used in the US needs upfront reporting to HHS.

Making Sure 'Reusable' Means 'Safe to Reuse'

The act also tackles the safety of reusable medical devices – think endoscopes or certain surgical tools used on multiple patients. It formally recognizes "rapid assessment tests" intended to ensure these devices are properly cleaned as medical devices themselves under the Federal Food, Drug, and Cosmetic Act (Section 4). Critically, it directs HHS to create and publish, within one year, a list of specific types of these rapid assessment tests.

Tests included on this list will need to come with validated instructions for use and data proving they actually work as intended. Once this list is published, the FDA will reject applications for clearance of any listed test type that doesn't include this required validation data and instructions (Section 4). The goal here is straightforward: to ensure the tests used to confirm a reusable device is safe for the next patient are reliable and used correctly, reducing potential infection risks.

The Practical Upshot

So, what does this mean on the ground? For patients, the intent is safer medical procedures through better oversight of device changes and more reliable cleaning verification for reusable tools. For hospitals and clinics, it could mean clearer instructions for device reprocessing and access to validated tests to confirm cleanliness. For medical device manufacturers, it translates to increased reporting requirements and the need to validate certain cleaning assessment tests, likely adding to compliance efforts and costs. The rules appear relatively clear (low vagueness), focusing directly on information flow and the validation of safety checks.