Antimicrobial Heart Valve Clinical Study Compromise Suggested By FDA Panel
This article was originally published in The Gray Sheet
Executive SummaryAntimicrobial-treated heart valves could be approved based on an 800 patient-year premarket study coupled with animal studies and stringent postmarket surveillance as an alternative to more burdensome premarket requirements, members of FDA's Circulatory System Devices Panel suggested June 30.
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