“The US Food and Drug Administration (FDA) on Thursday announced that it’s seeking more information on medical devices that are refurbished, reconditioned, rebuilt, remarketed, remanufactured, serviced or repaired in order to investigate a number of potential safety issues.”
Read the full article: Source: Refurbished Medical Devices: FDA Wants to Hear More From Industry | RAPS
Read the proposed rule:
Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments
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