Binita S Ashar, MD, MBA, FACS, MAMSE
Research Professor, Department of Surgical Sciences
Biosketch
Binita S. Ashar, MD, MBA, FACS, MAMSE is a general surgeon and member of the American College of Surgeons Academy of Master Surgeon Educators. She is a former senior leader at the U.S. Food and Drug Administration (FDA), where she guided innovation pathways for surgical technologies, including robotics, advanced surgical systems, and reconstructive devices for nearly 25 years. Her experience also includes national health policy roles, with contributions to pandemic preparedness and response at the White House and FDA. Dr. Ashar is originally from Kalamazoo Michigan, received her bachelors degree from the University of Michigan and medical degree from The Ohio State University College of Medicine. She completed her general surgery training at Cleveland Clinic, Fairview Hospital, and received her MBA from Johns Hopkins University Carey School of Business. She previously held clinical appointments at Bethesda Naval/Walter Reed Hospital and Inova Fairfax Hospital and served as an Assistant Professor at Uniformed Services University of the Health Sciences. She now advises surgical device manufacturers and global stakeholders on regulatory strategy and innovation, with particular interest in expanding access to advanced surgical care through robotics and digital health technologies.
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- Executive MBA 2004, Business Administration, School of Business, Johns Hopkins University
- Residency 1998, General Surgery, Cleveland Clinic
- MD 1993, Medicine, College of Medicine, The Ohio State University
- BS 1989, Biology, Liberal Arts and Sciences, University of Michigan-Ann Arbor
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- regulatory policy
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Ashar B.S., Al Kalaa M.O., Dohler M., Patel V. A readiness framework for tele-robotic surgery deployment in rural hospitals Journal of Robotic Surgery. 2026;20(1)
Ashar B.S., Selber J.C. A Competency-Based Privileging Model for Robotic Platforms JAMA Surgery. 2026
Abbasi A., Weltz A., Rivera D.R., Nagel S., Mehta G.U., Ashar B.S., Cunningham S.C. Opportunities for Pragmatic Design Elements in Surgical Trials JAMA Surgery. 2025;160(10):1133-1137.
Ashar B.S. Commentary on: US FDA Patient Decision Checklist for Breast Implants: Results of a Survey to Members of the Aesthetic Society, April 2022 Aesthetic Surgery Journal. 2023;43(2):160-161.
Ashar B.S., Yoon S.W., Nagel S. Breast implant–associated anaplastic large cell lymphoma American Family Physician. 2020;101(1):8-9.
Jaffe E.S., Ashar B.S., Clemens M.W., Feldman A.L., Gaulard P., Miranda R.N., Sohani A.R., Stenzel T., Yoon S.W. Best practices guideline for the pathologic diagnosis of breast implant–associated anaplastic large-cell lymphoma Journal of Clinical Oncology. 2020;38(10):1102-1111.
Ashar B. Assessing the Risks of Breast Implants and FDA's Vision for the National Breast Implant Registry Annals of Surgery. 2019;269(1):37-38.
McCarthy C.M., Loyo-Berríos N., Qureshi A.A., Mullen E., Gordillo G., Pusic A.L., Ashar B.S., Sommers K., Clemens M.W. Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE): Initial Report of Findings, 2012-2018 Plastic and Reconstructive Surgery. 2019;143(3):65-73.
Chang C.J., Ashar B.S., Marquart L.N. The US food and drug administration's approach for safe innovation of medical devices in dermatology JAMA Dermatology. 2018;154(3):261-263.
Ashar B.S., Dang J.M., Krause D., Luke M.C. Performing clinical studies involving hernia mesh devices: What every investigator should know about the FDA investigational device exemption (IDE) process Hernia. 2011;15(6):603-605.
Ashar B.S., Ferriter A. Radiofrequency identification technology in health care: Benefits and potential risks JAMA. 2007;298(19):2305-2307.
Ferriter A., Ashar B. Radiofrequency identification technology: FDA technical and regulatory perspective for medical devices Journal of Biolaw and Business. 2007;10(3):52-54.
Ashar B., Barnett M., Schultz D. The critical path to new medical devices Biomedical Instrumentation and Technology. 2005;39(4):304-306.
Fuller J., Ashar B., Carey-Corrado J. Trocar-associated injuries and fatalities: An analysis of 1399 reports to the FDA Journal of Minimally Invasive Gynecology. 2005;12(4):302-307.
Ashar B.S., Schultz D.G. Surgical technology: a perspective from the FDA. Bulletin of the American College of Surgeons. 2003;88(3):32-33.