Dr. Robert E. Lee

Professional Overview

Dr. Robert E. Lee brings over 40 years of unparalleled expertise in vascular surgery, with a distinguished career that bridges clinical practice, academia, and regulatory leadership. Recently retired from the U.S. Food and Drug Administration (FDA), Dr. Lee is recognized for his work in streamlining regulatory pathways for medical devices, particularly those focused on renal care.

• 10+ years at the U.S. FDA on the Vascular & Endovascular Devices Team.

• Played a pivotal role in regulating vascular access devices.

• Advanced renal care through clinical trials and regulatory innovation.

As a Medical Officer on the Vascular & Endovascular Devices Team at the FDA, Dr. Lee:

• Led the evaluation and approval of innovative medical devices critical to vascular healthcare.

• Played a pivotal role in advancing regulation for vascular access devices.

• Oversaw clinical trials, ensuring devices met the highest standards of safety and efficacy.
  His leadership has significantly advanced renal care innovation and improved global patient outcomes.

Leadership at the FDA

Clinical & Academic Contributions

• Led Clinical Research in major hospitals, developing best practices for vascular access treatments.

• Developed Groundbreaking Vascular Access Solutions, significantly improving patient outcomes in renal care.

• Advanced Vascular Surgery Standards, influencing global treatment protocols and guidelines.

• Served as Faculty and Educator, mentoring the next generation of vascular surgeons and researchers.

• Contributed to Policy Development in medical societies, enhancing regulatory frameworks for new vascular devices.

Regulatory Pathways: Navigating FDA submissions and compliance.

Clinical Trials Oversight: Ensuring safety and efficacy.

Vascular Access Innovation: Advancing treatments in renal care.

Renal Care Leadership: Improving patient outcomes globally.

Areas of Expertise