We welcome you to join fellow perfusionists to hear from Catherine Wentz, M.S., from the U.S. Food & Drug Administration. The regulatory process for approving medical devices and reporting adverse events for marketed medical devices remains a mystery to most non-regulators. The presentation will review this process and provide some clarity regarding what is behind the clearance/approval process and how the FDA relies on medical professionals to share post-market issues with these devices.
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