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Suzanne Schwartz, MD, MBA

Director – Office of Strategic Partnerships & Technology Innovation (OST) at CDRH
US FDA

Dr. Schwartz leads the Office of Strategic Partnerships and Technology Innovation, which provides leadership for all scientific collaborative and emerging technology related activities at the Center for Devices and Radiological Health (CDRH). Represent CDRH with a broad and diverse array of national and international entities including other government agencies, Congress, industry, academia, consumer and patient organizations, and healthcare professional organizations, with mutual interests in medical devices and radiation-emitting products. Provide leadership in advancing partnerships with patient organizations, healthcare professional organizations, industry, scientific and other external organizations to support broad national and international patient-focused and regulatory science programs and activities related to the innovation, safety, effectiveness, and quality of medical devices and the safety of radiation-emitting products. Provide leadership and facilitate collaboration in fostering the development of medical devices to respond to unmet public health needs and to address challenges of bringing innovative medical devices to market that are safe, effective and high quality. Provide leadership and strategic direction on medical device cybersecurity, software, and digital health, including the Software Pre-certification program. Provide leadership, oversight, and coordination for CDRH in matters relating to public health emergency preparedness and response activities involving CDRH-regulated products or facilities. Provide world-wide leadership in standards implementation and use for medical device innovation and manufacturing, and radiation-emitting product safety. Direct and oversee the Center's data, technology, and IT transformation services to ensure effective design, development, and utilization of information systems, electronic data and analytic capabilities to optimize regulatory business processes.

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