Carolyn Dorgan, BBME, MS FDA

Mrs. Dorgan serves as a Senior Lead Reviewer and Combination Products Team Lead in the General Hospital Device Branch in CDRH’s Office of Device Evaluation.  Within the Agency, Carolyn serves as the Agency’s standards liaison for over nine international standards, is part of the team developing three device specific guidance documents, participates on the Pediatric Steering Committee, and is a member of the Pediatric Extrapolation Review Committee. Prior to joining the FDA, Carolyn worked in the medical device industry for 5 years as an engineer. Carolyn earned her Bachelor’s Degree in Biomedical Engineering from the University of Minnesota and her Master’s Degree in Technology Commercialization from the University of Texas.