PhD, Assistant Director, Peripheral Interventional Devices, CDRH
US Food and Drug Administration
Misti Malone, PhD is the Assistant Director of the Peripheral Interventional Devices Team in the Office of Cardiovascular Devices in the Center for Devices and Radiological Health at FDA. Following completion of her doctorate in Biomedical Engineering, she joined FDA in 2012 as a lead reviewer for vascular surgery and peripheral interventional devices. As the Assistant Director, her primary responsibilities involve regulatory oversight of peripheral vascular devices across the total product life cycle, including submission review and internal and supporting external partnerships to bolster efficient device evaluation. She is actively involved in collaborations related to collection of global clinical evidence and real-world evidence to support clinical and regulatory decision-making as part of RAPID (a multi-stakeholder registry collaborative), the US-Japan Harmonization By Doing group promoting global regulatory solutions, and various other groups to support strategic priorities and FDA’s mission. She has authored several publications in various journals to share her group’s review perspectives.
Tuesday, September 15, 2020
1:00 PM – 2:30 PM EDT