Robert E. Lee, MD

Robert E. Lee, MD is a medical officer from the Vascular Surgery Devices Branch in the Division of Cardiovascular Devices, Office of Device Evaluation, Center for Devices & Radiologic Health, US Food and Drug Administration, in Silver Spring, Maryland. The Vascular Surgery Devices Branch has the responsibility for the premarket reviews of many of the devices used either to create dialysis access with fistulas or prosthetic grafts, or to treat the venous stenosis that is the bane of angioaccess providers and patients. 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 in 2015, he practiced vascular and endovascular surgery in southeast Michigan for three decades, where providing access for hemodialysis was a significant component of his clinical activity. Dr. Lee is a coauthor of the paper "FDA Regulatory Perspectives for Studies on Hemodialysis Vascular Access" recently published in the Clinical Journal of the American Society of Nephrology.