BIO
James
Bertram
Director, Office of Combination Products
FDA
James Bertram is Director of the Office of Combination Products (OCP) at the FDA, overseeing assignment, review coordination, and postmarket activities of combination products. Previously, he was Associate Director with the Regulatory Policy and Combination Products Staff in the Office of Product Evaluation and Quality, and served as a Product Jurisdiction Officer representing CDRH across the FDA, collaborating on cross-cutting activities. He holds a BS in Mechanical Engineering from Penn State and an MS/PhD in Biomedical Engineering from Yale. James joined the FDA in 2009 as a Regenerative Medicine Fellow in the Commissioner's Fellowship Program.
