Ms. Allison Kumar

Emergency Preparedness/Operations and Medicial Countermeasures Program
FDA's Center for Devices and Radiological Health

Allison Kumar is a Sr. Program Manager with the Emergency Preparedness and Medical Countermeasures (EMCM) Program in the Office of the Center Director at the FDA’s Center for Devices and Radiological Health (CDRH) with over 15 years of combined experience with the US Food and Drug Administration and In Vitro Diagnostics industry. In her Sr. Program Manager role, Ms. Kumar develops collaborations and works as a liaison between medical device developers in government agencies, DoD, academia, and industry and the CDRH review divisions to reduce the regulatory hurdles that often accompany bringing novel, high-risk, high-benefit innovative technology to market, by aligning early device development activities with FDA’s regulatory expectations.  Prior to joining EMCM, she spent 5 years inthe CDRH Office of Device Evaluation as a sr. pre-market reviewer, providing primary contributions to regulatory management of 510(k), IDE, and PMA devicesin the Division of Cardiovascular Devices. Ms. Kumar holds a bachelor’s degree in Biomedical Engineering, a graduate certificate in Biohazardous Threat Agents and Emerging Infectious Diseases from Georgetown University, and is a graduate of the Harvard School of Public Health’s National Preparedness Leadership Institute.