Virtual Product Responsibility Summit 2020: Emergency Use Authorization
|What is the FDA’s Emergency Use Authorization (EUA)? What does it mean to you and what will happen when it expires? This session will qualify as an elective for the Product Safety Awareness initiative and is as an elective for the Product Safety Awareness initiative.|
Dr. Suzanne Schwartz
FDA's Deputy Director Office of Strategic Partnerships & Technology Innovation, Center for Devices & Radiological Health
Suzanne Schwartz, MD, MBA is FDA's Deputy Director (& Acting Office Director) Office of Strategic Partnerships & Technology Innovation (OST), Center for Devices & Radiological Health, US Food & Drug Administration. Suzanne joined FDA in 2010 as a Commissioner’s Fellow and joined CDRH the following year as a Medical Officer in the former Office of Device Evaluation, Division of Surgery, Orthopedics and Restorative Devices. Soon after, Suzanne became CDRH’s Director of Medical Countermeasures and Emergency Preparedness/Operations (EMCM) in the Office of the Center Director. In this role, she provided leadership in the strategic planning and implementation of CDRH’s medical countermeasures, counter-terrorism, and public health emergency preparedness/operations initiatives involving medical devices. Suzanne began spearheading CDRH’s medical device cybersecurity strategic initiative while in her role as Director of EMCM in 2013, chairing the CDRH Cybersecurity Working Group which is tasked with formulating policy on medical device cybersecurity on behalf of the Agency. In 2015, Suzanne assumed the position of CDRH’s Associate Director for Science and Strategic Partnerships, where she provided leadership and strategic direction for additional Center programs such as Partnering with Patients, External Expertise and Partnerships, the Standards Management Program, as well as initiatives to advance the health of women, children, and special populations. 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. Most recently, Suzanne earned a certificate of mastery for all requirements set forth in the Leadership for a Democratic Society, conferred by the Federal Executive Institute, US Office of Personnel Management.
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