DEVICE Act of 2025

Increased Transparency in Design and Cleaning Changes: Under Section 2, manufacturers must provide written notice to the Secretary before changing a device's design or its instructions for reprocessing. This ensures the government is informed of changes that could affect how devices are used or cleaned.

Faster Reporting of International Safety Information: Section 3 requires manufacturers to notify the Secretary within five calendar days if they widely disseminate information to foreign health care providers regarding design changes, reprocessing protocols, or safety concerns. This provides a quick window for the Secretary to be aware of information being shared abroad.

Standardization of Cleaning Verification Tools: Section 4 expands the definition of a medical device to include rapid assessment tests used to ensure reusable devices are properly sanitized. This includes a requirement for the Secretary to establish a list of these tests that must include validated instructions for use and validation data, which helps ensure these tools are effective for keeping devices safe and effective.

Increased Regulatory Burden for Manufacturers: Under Section 2, manufacturers are now required to give written notice to the Secretary before making changes to the design or reprocessing instructions of a device marketed in interstate commerce.

Strict Communication Timelines: Section 3 creates a requirement for manufacturers to report certain communications to foreign health care providers within a strict five-calendar-day window.

New Compliance Requirements for Assessment Tests: Section 4 requires the Secretary to develop a list of rapid assessment tests that must include specific validated instructions and data, and the Secretary will not accept notifications for these tests unless they meet these specific standards.