Lee Kramm MD, MSE

Lee Kramm is a Board-certified ophthalmologist and regulatory professional who served as a medical officer and senior reviewer at the Division of Ophthalmic, Neurological and ENT Devices (DONED) at FDA. He has worked as a consultant since 2012, first under ClinReg Consulting and now with Regulatory Pathways Group, providing clients with clinical and regulatory advice on the FDA pathway for devices, biologics, and drug products. Dr. Kramm has reviewed and prepared clinical trial plans, classification opinion memos, de novo petitions, pre-submissions, IDEs, INDs, PMAs, 510(k)s, HUDs, NDAs, Breakthrough Designations, and requests for designation. His services also include standing as official correspondent for communications between clients and regulatory bodies. He earned his Master of Science in Biomedical Engineering from the Tulane University School of Science and Engineering and his medical degree from the University of Miami School of Medicine before completing his Ophthalmology training.