Danica Marinac-Dabic, MD, PhD, MMSc

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US Food and Drug Administration, Silver Spring, MD
Stakeholder Council, MDEpiNet


Background

Dr. Marinac-Dabic is the Director of the Division of Epidemiology in the Office of Surveillance and Biometrics Center for Devices and Radiological Health at the FDA. She has over twenty years of experience in obstetrics, gynecology, perinatal epidemiology, and regulatory science and surveillance settings. A physician and an epidemiologist by training Dr. Marinac-Dabic is in charge of scientific oversight of all device postmarket studies mandated by FDA either as a condition of approval or anytime postmarket. Dr. Marinac-Dabic also oversees the CDRH’s Epidemiologic Regulatory Science Program charged with advancing the methodologies and infrastructure for evidence development and appraisal with application to medical device regulatory science.Under Dr. Marinac-Dabic’s leadership, in 2010 FDA launched its Medical Device Epidemiology Network (MDEpiNet) Initiative to develop national and international infrastructure and innovative methodological approaches for conducting robust studies and surveillance to improve medical device safety and effectiveness understanding throughout the device life cycle through Public Private Partnership with academia and other stakeholders. Dr. Marinac-Dabic also leads the FDA’s International Consortium of Orthopedic Registries (ICOR) Initiative (launched in 2011) focusing on innovative approaches to regulatory science and surveillance for orthopedic medical devices and procedures through distributed model of over 30 national and international orthopedic registries capturing information on over 3.5 million orthopedic procedures worldwide.

Under her leadership, in 2013 the FDA launched its International Consortium of Cardiovascular Registries Initiative designed to expand collaborative work between international cardiovascular registries and integrate it into medical device regulatory science, active surveillance and comparative effectiveness and safety research. Dr. Marinac-Dabic served as a Chair, of Medical Device Special Interest Group at International Society for Pharmacoepidemiology and Therapeutic Risk Management. She also serves on the Steering Committees of STS/ACC Transcathether Valve Therapies Registry, AHRQ-funded TJ FORCE Registry, ICOR, and Oxford-based IDEAL Collaborative. Dr. Marinac-Dabic authored several book chapters, several dozens of manuscripts and invited presentations on various topics in the fields of medical device epidemiology and surveillance, registry development and utilization for medical device research, innovative methods for evidence synthesis and comparative effectiveness and safety research. She holds an Adjunct Professor position with several academic institutions.

Prior to coming to FDA, Dr. Marinac-Dabic garnered experience in obstetrics, gynecology, and epidemiology in the academic and hospital settings as well as teaching experience in academic environment.