FDA Releases Final Guidance to Clarify Device ‘Remanufacturing’

The U.S. Food and Drug Administration (FDA) issued final guidance for clarity on the definition of “remanufacturing” for reusable medical devices that need maintenance or repair.
 
The guidance aims to ensure consistency about what constitutes remanufacturing activities and promote more understanding of federal law and regulations around remanufacturing. The guidance was released due to extensive postmarket review and public comments that highlighted the need for clarity due to different regulatory implications between medical device “servicing” and “remanufacturing.”
 
By the FDA’s definition, remanufacturing is 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. Servicing is 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.”
 
Remanufacturing, according to the agency, is simply when a major alteration is made to a device’s performance, safety specifications, or intended use—changing from what was legally marketed or approved, cleared, or authorized by the FDA.
 
The agency also defined third-party servicers as “entities, other than the manufacturer or healthcare delivery organizations using the device, that maintain, restore, refurbish, repair or service a finished device after distribution, for purposes of returning it to the safety and performance specifications established by the OEM and to meet its original intended use.”
 
The guidance also recommend specific information be including in reusable device labeling about preventive maintenance and repair. This includes instructions for adequately returning a device to OEM-established performance and safety specifications.
  
The FDA affirmed that labeling recommendations don’t encourage disclosure of trade secrets or confidential commercial information and that regulations or policies shouldn’t be an impediment to sharing information, tools, and access to third-party servicers.
 
“Today’s action represents an important step forward in our mission to assure continued patient access to high-quality, safe and effective medical devices,” said Jeff Shuren, MD, J.D., director of the FDA’s Center for Devices and Radiological Health. “This guidance provides important clarity on defining remanufacturing and helps to remove perceived barriers to obtaining repair or maintenance of a device if it does not alter the safety, performance, or intended use.”
 
The FDA’s final guidance document can be viewed here.