FDA Public Reman Workshop on Medical Devices

The Food and Drug Administration (FDA) is announcing a public Workshop entitled "Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers." The topics to be discussed are the current regulatory environment for these activities, the definitions of the various terms FDA proposed in our prior Federal Register notice on this subject, and whether these activities should appropriately be regulated by FDA or a non-governmental organization.


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