Lee Kramm

Lee Kramm, MD

President

ClinReg Consulting Services

Biography

Dr. Lee Kramm is a board-certified Ophthalmologist with a Masters’ degree in Biomedical Engineering. He earned his graduate degree from the Tulane University School of Engineering and his medical degree from the University of Miami School of Medicine. Following medical school he received general and surgical training in Ophthalmology from the Rocky Mountain Lions Eye Institute at the University of Colorado in Denver. Dr. Kramm served for five years as a medical officer and scientific reviewer in the Division of Ophthalmic, Neurological and ENT Devices in the Center for Devices and Radiological Health, FDA. In his position as a medical officer at FDA, Dr. Kramm reviewed a variety of ophthalmic devices and served on several internal FDA working groups whose goal was to improve and bring consistency to premarket regulation and clinical evaluation. During his tenure at FDA, Dr. Kramm reviewed pre-IDEs, IDEs, PMAs, 510(k)s, Humanitarian Use Designations (HUD), Humanitarian Device Exemptions (HDE), Class I/II device recalls, combination products and requests for designation (RFD). As a part of ClinReg Consulting Services since 2012, he has been providing regulatory and clinical guidance to further the development of drugs, biologics and medical devices, primarily focused on meeting the US FDA premarket requirements.

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