Recently (09 May, 2024) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released the final guidance "Remanufacturing of Medical Devices" to promote a better understanding of applicable federal law and regulations implicated by remanufacturing activities, the final guidance seeks to ensure consistency regarding what constitutes remanufacturing activities.
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.
Medical device manufacturers need clarification on what constitutes remanufacturing for reusable devices that need maintenance or repair. This guidance addresses activities performed on devices that are intended to be reused and maintained.
This guidance discusses whether activities performed by OEMs and third parties on such devices are likely remanufacturing. Further, the guidance recommends labeling reusable medical devices with information about preventive maintenance and repair, such as instructions on how to adequately restore the device to its OEM specifications for performance and safety.
Regardless of whether a company self-identifies as a service provider or a remanufacturer, FDA focuses on the activities it performs on a particular device. The determination of whether the activities an entity performs are remanufacturing affects the applicability and enforcement of regulatory requirements under the FD&C Act and its implementing regulations.
To understand the relevant considerations to determine if activities are remanufacturing and to see more examples click this LINK.
Commentaires