Carl Fischer, PhD FDA

Carl Fischer is a Senior Advisor with FDA’s Center for Devices and Radiological Health, Office of Compliance, providing guidance on complex regulatory and scientific issues. Carl joined the FDA in 2009 as a biomedical engineer in the Office of Compliance’s Ob/Gyn, Gastroenterology & Urology Devices Branch. Since then, he has held various positions throughout FDA’s Office of Compliance, including Chief of General Hospital Devices Branch and Director of the Division of International Compliance Operations. He has broad experience with a wide variety of devices and combination products and has had extensive involvement with major FDA medical device cases and policy initiatives. Over the last few years he has been particularly involved in the evolution and implementation of the Medical Device Single Audit Program (MDSAP) at FDA. Carl received his B.S. in Biomedical Engineering from Johns Hopkins University and his M.S. and Ph.D. in Biomedical Engineering from the University of Texas at Arlington and University of Texas Southwestern Medical Center joint program in Biomedical Engineering.