Thinh X. Nguyen brings more than 33 years of experience at the U.S. Food and Drug Administration (FDA), with deep expertise in medical devices, combination products, regulatory policy, and cross-Center regulatory programs. Throughout his FDA career, Mr. Nguyen held senior leadership and technical roles focused on developing regulatory policy and guidance, resolving complex product classification and review issues, and advancing collaboration across the Agency.
Mr. Nguyen most recently served in FDA’s Office of the Commissioner as Acting Deputy Director of the Office of the Chief Medical Officer where he supported the FDA’s Chief Medical Officer in overseeing more than 100 scientists, clinicians, engineers, and support staff working across combination products, clinical research, evidence generation, rare diseases, and pediatric medical products. He also advised FDA’s Chief Medical Officer and helped resolve industry appeals involving orphan drug designation and medical product classification decisions. Prior to that, he was Director of the Office of Clinical Policy and Programs.
For nearly 15 years, Mr. Nguyen served as Director of FDA’s Office of Combination Products, where he oversaw product classification and jurisdiction, combination product policy and guidance, and the resolution of regulatory and review challenges involving FDA’s drug, biologic, and medical device Centers. Earlier in his FDA career, he held leadership and scientific review roles within the Center for Devices and Radiological Health, including Chief of the Premarket Approval Section and Acting Associate Office Director in the Office of Device Evaluation.
Before joining FDA, Mr. Nguyen was an electronics engineer with the U.S. Department of Defense’s Naval Electronics Systems Engineering Center. He holds a B.S. in Electrical Engineering, with honors, from North Carolina State University.