Surgical Device Regulatory Strategy: FDA Expertise for Complex Pathways
Binita S. Ashar, MD, MBA, FACS, MAMSE
Board-Certified Surgeon, Former FDA Office Director
Services
Enterprise Partnerships
Ongoing Regulatory Strategy
I help leading device companies navigate moments where regulatory strategy, clinical evidence, and market timing must align. Drawing on two decades leading FDA review and policy, I identify risks and pathways your team may miss.
Failed clinical trials, emerging safety issues, or uncertainty about FDA expectations—I help companies navigate these inflection points. Drawing on twenty-five years of FDA leadership and surgical practice, I identify the path forward.
