Thinh Nguyen

Thinh Nguyen

Director, Office of Combination Products, FDA

Mr. Nguyen is the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration since January 2008. OCP is primarily responsible for making jurisdictional determinations, coordinating premarket reviews, ennsuring consistent and appropriate postmarket regulations, and developing policy, guidance, and regulations. Prior to joining OCP, Mr. Nguyen spent 7 years as the Director for the Premarket Approval Section in the Center for Devices and Radiological Health where he played a key role in the passage of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the Medical Device User Fee Amendment of 2007 (MDUFA) legislations. During this time, he had established significant policies and written numerous guidance documents relating to the PMA programs (e.g., expedited review, user fees, PMA actions). Prior to coming to the FDA, Mr. Nguyen worked as a senior electronics engineer for the Naval Electronics Systems Engineering Center, Portsmouth, VA, from 1986 to 1993 where he was responsible for developing hardware/software for testing aircrafts and radar systems. Mr. Nguyen received a bachelor degree with honor in Electrical Engineering degree from North Carolina State in 1986.

Events Thinh Nguyen will be attending:

  • Combination Products Summit

  • Combination Products Registration