FDA issues final guidance on medical device remanufacturing definition for reusable devices.
The FDA has issued final guidance to provide the medical device industry clarity on the definition of "remanufacturing" for reusable devices needing maintenance or repair. The final guidance aims to ensure consistency regarding remanufacturing activities and to enhance understanding of applicable federal laws and regulations. The guidance follows an extensive review of postmarket information and consideration of public comments, highlighting the need for clarity between "servicing" and "remanufacturing" of medical devices.
May 09, 2024
5 Articles