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The Medical Event Review Committee focuses on proper definitions and descriptors of major adverse events following MCSD therapy, promotes consensus from industry as well as clinicians about the precise definitions of these events, proposes data elements which will aid in differentiating the underlying causes of adverse events as device-related, patient illness, and management-related. The committee reviews specified major clinical events, oversees the process of producing computer-generated Medical Device Reports (MDRs), and adjudicates the adverse events that initiate these FDA mandated reports.
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