Stephen Rhodes

Biography

    Mr. Rhodes is a Senior Director at Biologics Consulting Group (BCG), having joined BCG after more than 20 years of experience with the Food and Drug Administration, Center for Devices and Radiological Health. Most recently, he was the Director of the Investigational Device Exemptions (IDE) and Humanitarian Device Exemptions (HDE) programs in the Office of Device Evaluation. Mr. Rhodes had oversight for policy development for all device clinical trials. Prior to his role as Director of the IDE and HDE Programs, he served as chief of the Plastic and Reconstructive Surgery Devices Branch in ODE from 1996 until 2007. He had responsibility and oversight for 510(k) s, IDEs, PMAs and HDEs. Mr. Rhodes joined the FDA as a biomedical engineer in the Orthopedic Devices Branch, where he was a lead reviewer on over 350 510(k) applications, 40 IDEs and 6 Premarket Approvals (PMAs).  

Research Interest