Xiaolin (Lin) Zheng, PhD, is the deputy director for the Office of Neurological and Physical Medicine Devices (OHT5) within the Office of Product Evaluation and Quality (OPEQ) in the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration. In this role, she helps lead the regulatory evaluation and oversight of neurological and physical medicine medical devices, working to ensure these technologies are safe and effective for patient use in the United States. Dr. Zheng has been with the FDA since 2010 and brings deep expertise in medical device regulation and policy, particularly in the neurological device space, and contributes to initiatives that advance innovation while maintaining public health protections.

Prior to her current leadership position, Dr. Zheng served as director of the Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices within OHT5 at CDRH, where she guided multidisciplinary teams in the review of complex medical technologies used in open neurosurgery, neurointerventional procedures, and neurodiagnostic devices. Her work at FDA includes engagement in regulatory science, device classification initiatives, and efforts to streamline and ensure transparent pathways for clinical and commercial development of neurological devices. She earned her MS and PhD in chemical engineering from Washington University in St. Louis.

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