On March 4, 2016 the FDA released “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Requests for Comments.”

The FDA stated they are “taking this action, in part, because various stakeholders have expressed concerns about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities that are performed by both original equipment manufacturers (OEM) and third parties, including healthcare establishments.”

This article from Medical Dealer magazine, goes into further detail about the FDA docket, and provides insights on the origin, industry implications, and possible ramifications.

Click here to read the full article.