Jessica Paulsen

Associate Director for Digital Health in the Office of Product Evaluation and Quality (OPEQ)

Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA)

Moderated Sessions

September 21, 2023 | 03:15 PM (PST) - 04:15 PM (PST)

About Jessica Paulsen

Jessica Paulsen is the Associate Director for Digital Health in the Office of Product Evaluation and Quality (OPEQ) in the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA). She provides executive leadership and strategic oversight of OPEQ’s digital health review practices and policy implementation. She also leads the Center’s Digital Health Focal Point Program which aims to promote communication, collaboration, and consistency in digital health product reviews across CDRH. She previously served as the Director for the Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices in CDRH. She earned her B.E. in Biomedical Engineering and Engineering Management from Vanderbilt University.

Disclosures

No relevant financial relationships to disclose.