Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2023 or the DEVICE Act of 2023
This bill addresses design changes and reprocessing of medical devices. (Reprocessing of medical devices is the process for cleaning and sterilizing or disinfecting devices for reuse.)
Specifically, medical device manufacturers must notify the Food and Drug Administration (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.
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