FDA clarifies definition of 'remanufacturing' for medical devices needing maintenance

The Food and Drug Administration May 9 released final guidance clarifying the definition of “remanufacturing” for reusable medical devices needing maintenance or repair, advising that manufacturers include instructions necessary for proper servicing and provide examples of activities that constitute remanufacturing. The final guidance is in response to public comments, including from the AHA, which highlighted the need for clarity, considering the different regulatory implications between “servicing” and “remanufacturing” of a medical device. The FDA defines remanufacturing as “the processing, conditioning, renovating, repackaging, restoring or any other act done to a finished device that significantly changes the finished device’s performance, safety specifications or intended use." The agency also defines servicing as “the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications established by the original equipment manufacturer (OEM) and to meet its original intended use.” The agency also recommends certain information be included in the labeling of such devices regarding preventive maintenance and repair, including instructions on how to adequately return a device to its performance and safety specifications established by the OEM.