FDA Issues Final Guidance to Clarify “Remanufacturing” of Devices that Need Maintenance or Repair

Today, the U.S. Food and Drug Administration 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 seeks to ensure that there is consistency regarding what constitutes remanufacturing activities and to promote a better understanding of applicable federal law and regulations implicated by remanufacturing activities. The final guidance was issued following the agency’s extensive review of postmarket information and consideration of public comments, which highlighted the need for clarity, considering the different regulatory implications between “servicing” and “remanufac...