Bill > HR2372

This bill, known as the DEVICE Act of 2025, proposes several key changes to the Federal Food, Drug, and Cosmetic Act to improve medical device safety and communication. First, it requires medical device manufacturers to provide written notice to the FDA before making any changes to a device's design or reprocessing instructions, which would now be considered a violation that could render the device adulterated. Second, the bill mandates that manufacturers report to the FDA within 5 calendar days any communications about device design changes, reprocessing protocols, or safety concerns that are widely shared with foreign healthcare providers. Third, the legislation expands the definition of medical devices to include rapid assessment tests designed to ensure proper reprocessing of reusable devices, and it requires manufacturers to provide validated instructions and data for these tests. The bill aims to enhance transparency, safety, and communication in the medical device industry by creating new reporting requirements and standards for device manufacturers, ultimately helping to protect patient safety and improve medical device quality control.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/2372/all-info