The DEVICE Act of 2025 would expand and formalize FDA-regulated communications and reprocessing oversight for medical devices. It adds new reporting obligations on manufacturers before making design changes or updating reprocessing instructions, and it creates a separate, time-bound requirement to notify the federal secretary about certain communications that are widely disseminated to foreign health care providers about device design changes, reprocessing changes, or safety concerns. The bill also introduces a new category of rapid assessment tests intended to ensure proper reprocessing of reusable devices and requires manufacturers to provide validated instructions for use and validation data for these tests. In addition, the bill ties compliance to adulteration penalties, meaning failure to meet these reporting requirements could render a device adulterated under current law. Overall, the bill aims to improve patient safety and device cleanliness by increasing transparency around design changes and reprocessing practices, speeding the flow of safety information internationally, and creating standardized validation and usage data for rapid reprocessing tests. It would impose new compliance burdens on device manufacturers, especially for reusable devices, and give FDA additional enforcement tools.
Key Points
- 1Before any design change or change to reprocessing instructions for a device marketed in interstate commerce, manufacturers must give written notice to the Secretary (FDA). A violation can render the device adulterated under existing law.
- 2Introduces a new adulteration trigger (Section 501(k)) for manufacturers that fail to meet the 510(r) reporting requirement for design and reprocessing changes.
- 3Adds a new reporting requirement (510(s)) for communications to foreign health care providers. If a manufacturer or affiliate disseminates a communication about a device’s design change, reprocessing changes, or safety concerns to foreign providers, the manufacturer must notify the Secretary within 5 calendar days.
- 4Creates a new category of devices and tests: “rapid assessment tests” intended to ensure proper reprocessing of reusable devices. A reusable device is defined as one used more than once and requiring sanitization/preparation to be safe for reuse.
- 5Requires instructions for use and validation data for rapid assessment tests. The Secretary must publish an initial list of rapid assessment tests covered by this requirement within one year of enactment and periodically update the list. Beginning when the list is published, FDA cannot accept 510(k) notifications for clearance of a rapid assessment test unless those notifications include validated instructions for use and validation data.