AFDO RAPS Healthcare Products Collaborative
BIO
James Bertram

James

Bertram

 Director, Office of Combination Products

FDA

James Bertram is currently the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration (FDA). OCP is responsible for the assignment of combination products to FDA’s medical product centers for review, helps coordinate timely, effective, and aligned reviews of combination products and oversees the postmarket activities of combination products. Prior to joining OCP, James was the Associate Director with the Regulatory Policy and Combination Products Staff which supported the Office of Product Evaluation and Quality in CDRH. In addition, he served as a Product Jurisdiction Officer representing CDRH across the FDA. In this capacity, James collaborated across the Agency on cross-cutting activities, many of which apply to the review and regulation of combination products. After receiving a BS in Mechanical Engineering from Pennsylvania State University and a MS/PhD in Biomedical Engineering from Yale University, James joined the FDA in 2009 as a Regenerative Medicine Fellow in the Commissioner’s Fellowship Program. 

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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