FDA considers the need for additional regulation of the medical equipment service/refurbishment industry.
The purpose of this blog is to make sure all of the independent service and sales organizations (“ISO’s”) are aware of a recent FDA “docket” item. It is, according to the FDA, to receive comments “concerning the service, maintenance, refurbishment and alteration of medical devices by third-party entities, as well as challenges third-party entities face in maintainging or restoring devices […]