Dr. Danica Marinac-Dabic is the Director of Epidemiology at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) and sits on the International Scientific Collaboration (ISC) Committee.
Danica Marinac-Dabic, MD, PhD, MMSc, FISPE is the Director of the Division of Epidemiology at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). 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 device postmarket studies mandated by FDA. 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/international infrastructure and innovative methodological approaches for conducting robust studies and surveillance to improve medical device safety and effectiveness during the device life cycle through public and private partnerships with academia and other stakeholders.
Director of Epidemiology at the Food and Drug Administration
In this context Dr. Marinac-Dabic leads the FDA’s International Consortium of Orthopedic Registries (ICOR) Initiative (launched in 2011) focusing on the development and utilization of a model that incorporates over 30 national and international orthopedic registries and captures information on over 5.5 million orthopedic procedures worldwide.
Under her leadership, in 2013 FDA launched its International Consortium of Cardiac Registries (ICCR) and in 2014 International Consortium of Vascular Registries (ICVR) Initiatives designed to expand collaborative work between international cardiovascular registries and integrate it into medical device regulatory science, active surveillance, comparative effectiveness, and safety research.
Dr. Marinac-Dabic serves as a Fellow of the International Society of Pharmaco-epidemiology and Therapeutic Risk Management (ISPE), FDA Principal and member of the MDEpiNet Public-Private Partnership Executive Committee as well as a member of the Steering Committee of the STS/ACC Transcathether Valve Therapies (TVT) Registry, National Breast Implants Registry (NBIR), Oxford-based IDEAL Collaborative, and EXCITE International Collaborative. Dr. Marinac-Dabic also leads the Registry Working Group at the International Medical Device Regulators Forum (IMDRF) to develop international convergence of registry-generated data for regulatory decision making.
She has authored multiple book chapters, published several dozen manuscripts, and given numerous 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. 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.