Taller abierto al público de reacondicionamiento, refabricación y asistencia técnica de productos sanitarios realizado por entidades terceras y OEMs programado para los días 27 y 28 de octubre de 2016.
Ver más información en: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm511411.htm
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. On March 4, 2016, the FDA opened a docket to request comments from individuals and organizations engaged or otherwise interested in the Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices, including radiation-emitting devices subject to the electronic product radiation control provisions of the Federal Food, Drug, and Cosmetic Act. FDA took 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. This docket asked that Original Equipment Manufacturers (OEMs), health care establishments and third-party entities review proposed terms and definitions and provide edits if applicable. The docket also sought insights into basic concepts with regard to these activities. (View the docket and public comments)