ALEXANDRIA, Va.–(BUSINESS WIRE)–Biologics Consulting Group, Inc., a regulatory affairs consulting firm, is pleased to announce a key appointment to its highly-experienced team.
Biologics Consulting Group, Inc., today announced the addition of Stephen P. Rhodes, M.S. as a Senior Consultant. Mr. Rhodes brings over 20 years of experience with the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). Most recently, he was the Director of the Investigational Device Exemptions (IDE) and Humanitarian Device Exemptions (HDE) programs in the Office of Device Evaluation (ODE) – responsible for review and approval of most types of medical devices, and oversaw policy development for clinical trials. Concurrently, as the CDRH Product Jurisdiction Officer, he was responsible for recommendations to the Office of Combination Products regarding their jurisdiction. He also provided leadership on premarket provisions of the FDA Amendments Act of 2007.
From 1996-2007, he served as Chief of the Plastic and Reconstructive Surgery Devices Branch in the ODE. During his tenure as Branch Chief, Mr. Rhodes supervised the review and approval of the many of the first types of:
- breast implants
- tissue adhesives
- dural and pulmonary sealants
- neurological stents
- dermal fillers
- cellular products for wound care
- surgical meshes and wound care products containing animal source tissue and/or drugs
Mr. Rhodes’ prior FDA positions included Deputy Division Directorships in the Division of Cardiovascular Devices and the Division of Surgical, Orthopedic and Restorative Devices. His numerous awards at FDA include: Engineer of the Year Award, Outstanding Service Award, Public Health Service Commendation Medal, CDRH Scientific Achievement Award for Outstanding Intercenter Scientific Collaboration, and CDRH Excellence in Review Science Group Award. He holds a B.S. in Engineering Science and Mechanics from Virginia Polytechnic Institute and State University (Virginia Tech), a M.S. in Biomedical Engineering from Catholic University of America, and a joint M.S. in Device Biomedical Science and Technology Management from Georgetown University/Virginia Tech.
“It is a great day for the Biologics Consulting Group when we can bring in such a thought-leader to our medical device and combination products practice,” remarked Dr. Michael Salgaller, President and Chief Operating Officer. “Coming from the senior levels of CDRH, he will make a significant contribution towards one of the fastest growing sectors within our company.”
About Biologics Consulting Group, Inc.
Founded in 1993, Biologics Consulting Group is a fully integrated team of consultants who provide national and international regulatory and product development advice on the development and commercial production of biologics, drugs, and devices. Our staff consists of experts in regulatory affairs, product manufacturing and testing, pharmacology/toxicology, facility inspections, statistics, program management, and clinical trial design and evaluation. Our consultants include former CBER, CDER, and CDRH reviewers, certified FDA inspectors, and senior scientists from the biopharmaceutical industry.