The U.S. Food and Drug Administration (FDA) has released a draft guidance detailing the agency’s view of what constitutes a “remanufactured” medical device and to help clarify regulatory requirements applicable to such devices.
The draft guidance, “Remanufacturing and Servicing Medical Devices,” defines remanufacturing as “the processing, conditioning, renovating, repackaging, restoring or any other act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 or safety specifications, or intended use.”
“Servicing,” on the other hand, is defined in the draft guidance as “the repair and/or preventative or routine maintenance of one or more parts in a finished device…for the purpose of returning it to the safety and performance specifications established by the original equipment manufacturer (OEM) and to meet its original intended use.”
The FDA notes that this distinction is important in determining what regulations apply in evaluating the safety and performance of remanufactured medical devices. In brief, the draft guidance details that “the FDA enforces requirements under the FD&C Act and its implementing regulations on entities engaged in remanufacturing, including but not limited to registration and listing, adverse event reporting, the Quality System (QS) regulation, and marketing submission.”