Various stakeholders are urging the FDA to strengthen regulations for third-party providers that service and refurbish medical equipment being used in the field.
That call was echoed in comments to a proposed rule titled "Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers." The call for comments initially appeared in the March 4 Federal Register, but the agency extended the comment deadline to June 3 from May 3, after a number of stakeholders, including AdvaMed, asked for more time. Read More
