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Barb Marsden

Acting Office Director, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA (Virtual)

Barb Marsden serves as Acting Director in the Office of Regulatory Programs (ORP) within the Office of Product Evaluation and Quality at the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). In this role, she oversees the development, maintenance, and continuous improvement of regulatory processes that support medical device oversight across the total product life cycle.
Ms. Marsden has built a distinguished career at the FDA since joining the agency in 1994 as a Lead Reviewer in the Pacing and Electrophysiology Devices Branch within the Division of Cardiovascular Devices. Over the course of more than three decades, she has held a series of increasingly senior leadership roles within CDRH, including Branch Chief of the Orthopedic Devices Branch, Deputy Director of the Division of Cardiovascular Devices, Deputy Director in the Office of Device Evaluation, and Deputy Director in ORP.
In addition to her leadership responsibilities, Ms. Marsden has played a key role in advancing CDRH’s mission through her contributions to the negotiation and implementation of the Medical Device User Fee Amendments (MDUFA). She holds a Bachelor of Science in Electrical Engineering from Drexel University, providing a strong technical foundation that supports her work in regulatory science and medical device evaluation.

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