Roundtable on Active Medical Product Surveillance: Learning from The DELTA System and the Massachusetts Interventional Cardiology Device Safety Surveillance Pilot Project

On May 7, the Engelberg Center for Health Care Reform hosted the roundtable webinar, “The DELTA System and the Massachusetts Interventional Cardiology Device Safety Surveillance Pilot Project.”

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Discussion featured presentations from Dr. Thomas P. Gross, Deputy Director, Office of Surveillance and Biometrics, Center for Devices and Radiological Health (CDRH), Food and Drug Association (FDA), and Dr. Fredric S. Resnic, Medical Director, Cardiac Catheterization Laboratory, Brigham and Women’s Hospital. Panelists focused on the ongoing post-market surveillance work being done at CDRH and the Massachusetts interventional cardiology device safety surveillance pilot project using the Web-based DELTA (data extraction and longitudinal time analysis) system for identifying low frequency safety signals.