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AdvaMed Comments on Medical Device Servicing and Remanufacturing Activities

first page of AdvaMed Comments on Medical Device Servicing and Remanufacturing Activities

AdvaMed submitted these comments on the Food and Drug Administration’s (FDA or Agency) request for comment on medical device servicing and remanufacturing activities and the associated Public Workshop and White Paper entitled “Evaluating Whether Activities are Servicing or Remanufacturing.” AdvaMed supports FDA’s efforts to clarify remanufacturing activities as distinct from servicing activities via development of draft guidance (subject to our general and specific comments below) since many third-parties are, in effect, remanufacturing devices when they service them