Misti Malone, PhD, is the Chief of the Peripheral Interventional Devices Branch (PIDB) in the Division of Cardiovascular Devices at the Food and Drug Administration. PIDB is responsible for reviewing regulatory submissions to support clinical trials and marketing for devices to treat peripheral cardiovascular disease. As such, her group facilitates, communicates, and provides feedback to health leaders, global medical device industry sponsors, and physician investigators to bring safe and effective devices to treat peripheral cardiovascular diseases to patients and the market efficiently and predictably. Misti promotes innovation and collaboration between industry, academia, and regulatory bodies on several cross-cutting projects, including the Medical Device Epidemiology Network and the Harmonization by Doing Group between the U.S. and Japan.
Before joining the FDA, Misti completed her PhD at Johns Hopkins University in Biomedical Engineering and studied abroad at the Howard Florey Institute at the University of Melbourne under a Fulbright Fellowship.