Binita S. Ashar, MD, MBA, FACS, MAMSE
About
I am a board-certified general surgeon. I practiced before I joined FDA and continued clinical work for much of my time there. That order shapes my perspective.
I served at FDA from 2000 to 2025. I joined as a medical officer reviewing device clinical trials, later directed the Division of Surgical Devices and, from 2019, was Office Director for Surgical and Infection Control Devices at the Center for Devices and Radiological Health. I led roughly 120 scientists, engineers, physicians, and surgeons across three divisions, responsible for every general surgery, plastic surgery, and infection control device marketed in the United States.
Clarity Surgical Advisors is independent by design. Clients work directly with me, and my advice draws on how FDA weighs evidence and how devices perform in the operating room.
Background
The portfolio included surgical robots, skin lesion analyzers, breast implants, surgical staplers, dermal fillers, acellular dermal matrices, wound care and hemostasis products, personal protective equipment, and AI-enabled systems. I was the Senior FDA Official overseeing the General and Plastic Surgery Devices Advisory Committee from 2013 through 2025. During the COVID-19 public health emergency I directed cross-agency work on infection control technologies and surgical supply.
Earlier, from 2005 to 2006, I served as Special Advisor for Medicine and Public Health in the Office of Homeland Security Affairs, Office of the Vice President of the United States.
I founded Clarity Surgical Advisors in 2025.