Suzanne B. Schwartz, MD, MBA is the Associate Director for Science and Strategic Partnerships in the Center for Devices and Radiological Health (CDRH) at the FDA. She also continues to serve as the Director (Acting) of CDRH’s Emergency Preparedness/Operations and Medical Countermeasures program. Suzanne represents CDRH/FDA across inter-Agency initiatives for the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) for chemical, biological, radiological and nuclear threats (CBRN), natural disasters and emerging infectious diseases. As CDRH’s Emergency Operations Coordinator, Suzanne is responsible for preparedness and incident response to all public health concerns involving or impacting medical devices, including cybersecurity of medical devices and their networked systems. Her programmatic efforts have evolved beyond response to include increasing awareness, educating, outreach, partnering and coalition-building within the Healthcare and Public Health Sector (HPH). Suzanne chairs the CDRH Cybersecurity Working Group which is tasked with formulating policy on medical device cybersecurity on behalf of the Agency. She also serves as co-chair of the Government Coordinating Council (GCC) for the HPH Critical Infrastructure Sector, focusing on the sector’s healthcare cybersecurity initiatives. Suzanne earned an MD from Albert Einstein College of Medicine of Yeshiva University in New York in 1988, trained in General Surgery and Burn Trauma at the New York Presbyterian Hospital - Weill Cornell Medical Center; an executive MBA from NYU Stern School of Business in 2012, and completed Cohort X of the National Preparedness Leadership Initiative – Harvard School of Public Health & Harvard Kennedy School of Government executive education in June 2013.
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