DEVICE Act of 2025

Summary

Requires medical device makers to notify the FDA before changing device designs or instructions for how to clean/reprocess devices and to report certain communications to foreign health providers about design or safety changes within five days. Adds "rapid assessment tests" used to check proper reprocessing of reusable devices to the FDA’s device rules and requires those tests to include validated instructions and validation data in premarket 510(k) notices; the FDA must publish and maintain a list of such test types and can refuse 510(k) submissions that lack the required validation information.

• Manufacturers must give written notice to FDA before making design changes or changing device reprocessing instructions for devices sold in interstate commerce.
• Manufacturers must notify FDA within 5 calendar days after certain communications to foreign health care providers about design changes, reprocessing changes, or safety concerns.
• Failure to meet the new notice or reporting duties is treated as grounds for a device to be deemed "adulterated."
• Adds "rapid assessment tests" for verifying proper reprocessing of reusable devices to the legal device definition.
• FDA must publish and maintain a regulated list of rapid assessment test types and may refuse 510(k) submissions for listed tests that lack validated instructions and required validation data.
• FDA must publish the initial list within one year of enactment and update it periodically.
• The changes affect 510(k) premarket submissions by adding validation documentation requirements for listed test types.
• Hospitals and sterilization staff should receive tests and instructions with validated performance claims to assess reprocessing quality.
• Manufacturers will face increased compliance and documentation responsibilities, potentially raising development or regulatory costs and slowing changes to design or reprocessing guidance.
• The law uses existing FD&C Act enforcement tools (adulteration) to enforce the new notice and reporting duties.