About
Binita S. Ashar, MD, MBA, FACS, MAMSE, is Research Professor in the Department of Surgical Sciences at Western Michigan University Homer Stryker M.D. School of Medicine.
She serves on the boards of the Society of Robotic Surgery and the Institute for Surgical Excellence and is a member of the American College of Surgeons Academy of Master Surgeon Educators.
She spent nearly 25 years at the U.S. Food and Drug Administration. From 2018 to 2025, she served as Office Director, Office of Surgical and Infection Control Devices (OHT4), FDA Center for Devices and Radiological Health.
She is a board-certified general surgeon and advises companies on surgical devices, robotics, AI-enabled systems, clinical evidence, product safety, and regulatory strategy.
Background
At FDA, Dr. Ashar directed review and policy for general surgery, plastic surgery, reconstructive, aesthetic, and infection-control devices, including surgical robots, breast implants, surgical staplers, dermal fillers, wound-care products, hemostasis products, and AI-enabled systems.
During the COVID-19 public health emergency, she directed cross-agency work on infection-control technologies and surgical supplies.
From 2005 to 2006, she served as Special Advisor for Medicine and Public Health in the Office of Homeland Security Affairs, Office of the Vice President.
Selected Work
• Presided over General and Plastic Surgery Devices Advisory Committee meetings for more than a decade, including meetings on robotic surgery, breast implants, surgical staplers, dermal fillers, and AI-enabled technologies.
• Directed FDA review and policy for general surgery, plastic surgery, reconstructive, aesthetic, and infection-control device categories.
• Led cross-agency work on infection-control technologies and surgical supplies during the COVID-19 public health emergency.
• Served as an FDA spokesperson on breast-implant safety and other surgical-device safety issues.
Selected Publications and Media
JAMA Surgery - A Competency-Based Privileging Model for Robotic Platforms (2026)
Journal of Robotic Surgery - National telerobotic surgery framework
Johns Hopkins Public Health On Call - Advancing Robotic Telesurgery
FDA - Statements on breast implant safety and lymphomas