Skip to main content
Controversies in Dialysis Access (CiDA) Sym 2025 Main banner

Robert E. Lee, MD

Regulatory Consultant
Echelon Development Group
Grosse Pointe Shores, Michigan, United States

Robert E. Lee, MD served as a medical officer on the Vascular and Endovascular Devices Team in the Office of Cardiovascular Devices, Center for Devices & Radiologic Health, US Food and Drug Administration, in Silver Spring, Maryland from 2015 through 2024. Dr. Lee was first ABS certified vascular surgeon to serve as an FDA medical officer. The Vascular and Endovascular Devices Team has the responsibility for the premarket reviews and post-market surveillance of aortic endografts, prosthetic vascular grafts, other devices used in open vascular surgery, and many of the products used to create vascular access for hemodialysis or to treat dysfunctional AV access. Since retiring from FDA, Dr. Lee co-founded the Echelon Development Group, a consulting firm dedicated to helping companies facilitate the path for novel vascular access technology to market.

Dr. Lee is a native of Detroit and a graduate of the University of Michigan Medical School. He completed a general surgery residency and a vascular surgery fellowship at Henry Ford Hospital in Detroit. Dr. Lee is certified by the American Board of Surgery in both general surgery and vascular surgery. Prior to joining the FDA, he practiced vascular and endovascular surgery in southeast Michigan for three decades.

Disclosure information not submitted.

Presentation(s):