David McMullen

Dr. David McMullen serves as Director for the Office of Neurological and Physical Medicine Devices (OHT5) within the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration. CDRH advances medical device innovation by promoting regulatory science, ensuring predictable and transparent pathways for industry, and fostering public confidence in devices marketed in the United States.

OHT5, part of CDRH’s Office of Product Evaluation and Quality (OPEQ), oversees the total product lifecycle for neurological and physical medicine devices. As Director, Dr. McMullen is the principal advisor to the OPEQ Director and serves as the technical authority across premarket evaluation, compliance, quality, and postmarket surveillance for neurological devices.

Before joining the FDA in 2022, Dr. McMullen was Program Chief for the National Institute of Mental Health’s (NIMH) Neuromodulation and Neurostimulation Program in the Division of Translational Research. His portfolio included oversight of device development, biomarker discovery, and clinical trials spanning early feasibility through pivotal studies supporting regulatory submissions. He also co-led the NIH BRAIN Initiative device team and served as NIMH’s liaison to the FDA on device-related programs.

Dr. McMullen earned his Bachelor of Science in Psychology and Neuroscience from Duke University and his Doctor of Medicine from Rutgers Robert Wood Johnson Medical School.