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Misti Malone, PhD

Asst Director, PIDT
FDA
Silver Spring, Maryland, United States

Misti Malone, Ph.D., is the Assistant Director of the Peripheral Interventional Devices Team in the Office of Cardiovascular Devices at FDA. As the Assistant Director, her primary responsibilities involve regulatory oversight of peripheral vascular devices across the total product life cycle, including submission review and supporting internal and 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.

No relationships to disclose

Presentation(s):