Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2019 or the DEVICE Act of 2019
This bill addresses design changes and reprocessing of medical devices. Reprocessing of medical devices is the process to clean and sterilize or disinfect devices for reuse. Specifically, medical device manufacturers must notify the Food and Drug Administration (FDA) (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device. A device may not be sold if the manufacturer violates these notification requirements.
Rapid assessment tests intended to ensure the proper reprocessing of reusable medical devices are defined as medical devices. The FDA must publish a list of the types of rapid assessment tests for which premarket notification must include validated instructions for use and validation data.
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