Anindita “Annie” Saha, director of the FDA’s Division of Digital Health Outreach within the Digital Health Center of Excellence, has left the agency after more than 21 years.
Ms. Saha’s exit ends a tenure that spanned multiple leadership roles inside the FDA’s Center for Devices and Radiological Health. She most recently led the Division of Digital Health Outreach from July to September 2026, while also serving as acting associate director for data science and AI policy at the Center for Drug Evaluation and Research from July 2025 to September 2026.
Before those roles, Ms. Saha spent more than two years as associate director for strategic initiatives at the Digital Health Center of Excellence, and more than three years as the center’s assistant director. She joined the FDA in 2005 as a biomedical engineer and previously directed the Partnerships to Advance Innovation and Regulatory Science program within CDRH’s Office of Strategic Partnerships and Technology Innovation.
Ms. Saha said Sept. 7 on LinkedIn that it “feels a little surreal” to be leaving, and did not name a next employer. She said more details on her next steps are forthcoming.
Launched in 2020, the Digital Health Center of Excellence sets FDA strategy on regulating software as a medical device, wearables and AI-enabled tools, including its recent discussion paper on generative AI-enabled medical devices.
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