Meet Allison Kumar,
Executive Regulatory Affairs Advisor

Allison Kumar founded Arina Consulting in 2018 after working 10 years at FDA’s Center for Devices and Radiological Health (CDRH). Combining her FDA tenure with almost a decade of prior experience in the IVD and biotechnology industry has provided a comprehensive knowledge base for companies and investors that engage with Arina Consulting to leverage.

During her time at FDA, she spent five years as a Senior Program Manager in the Center Director’s Office and five years as a Senior Pre-market Reviewer in the Office of Device Evaluation. In her Senior Program Manager role, Ms. Kumar developed collaborations and worked as a liaison between medical device developers working 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. She held positions on government steering committees for various high-level, high priority development efforts including traumatic brain injury, combat casualty care, medical countermeasures, and emergency response to emerging infection, diseases and natural disasters. As a Senior Pre-Market Reviewer, Allison provided primary contributions to regulatory management of 510(k), de novo, IDE, and PMA devices in the Division of Cardiovascular Devices, including review and collaborative development of pre-clinical testing and clinical trial design.

Her time in industry has provided management experience in quality systems, regulatory affairs, in vitro diagnostics, biorepository operations, laboratory automation, verification and validation activities, and regulatory audits. Allison’s passion is in using her deep institutional knowledge to develop innovative

approaches that help companies successfully communicate product information to investors and FDA throughout the total product life cycle. Leveraging her years of reviewer experience, broad FDA exposure, and strong network, she develops actionable premarket strategies to guide medical device development programs through successful submission. She is also uniquely positioned to assist the investor community in due diligence of potential investment targets.

Ms. Kumar holds a bachelor’s degree in Biomedical Engineering from Virginia Tech, a graduate certificate in Biohazardous Threat Agents and Emerging Infectious Diseases from Georgetown University, and is a graduate of the Harvard T.H. Chan School of Public Health’s National Preparedness Leadership Institute.