Assistant Director, Digital Health Center of Excellence
US Food and Drug Administration
Anindita (Annie) Saha is the Assistant Director for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). Ms. Saha is leading the development of partnerships, regulatory science, strategic planning, and operations for the newly formed DHCoE to empower digital health stakeholders in advancing healthcare. Additionally, Annie helped incubate and continues to support CDRH’s patient science and engagement efforts to advance the science and adoption of patient input as evidence, including patient preference information (PPI), clinical outcome assessments (COAs) including patient-reported outcomes (PROs), and patient-generated health data (PGHD). These efforts include researching the use of digital health technologies to capture the patient perspective. Previously, Annie was the Director of Partnerships to Advance Innovation and Regulatory Science (PAIRS) where she oversaw a broad program portfolio, supporting a number of strategic partnership and regulatory science programs for CDRH. This included relationships with the Medical Device Innovation Consortium and other public-private partnerships, Network of Experts, Critical Path, and technology transfer. Ms. Saha began her FDA career as a researcher in the CDRH’s Office of Science and Engineering Laboratories in the Division of Imaging and Applied Mathematics in the area of imaging display technologies before moving to EEP to coordinate Critical Path and Regulatory Science activities for the Center. Ms. Saha has a Bachelor of Science in Bioengineering and Minor in History from the University of Pittsburgh. She was a student researcher at the McGowan Institute for Regenerative Medicine working in tissue engineering and wound healing.
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Wednesday, March 16, 2022
3:00 PM – 4:00 PM ET
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