Biologics Consulting Group, Inc.
is pleased to make the following announcement:

Stephen P. Rhodes, M.S. joined Biologics Consulting Group, Inc., as a Senior Consultant (Medical Devices) in March, 2010.

Mr. Rhodes comes to BCG with a wealth of knowledge from over 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. The Office of Device Evaluation is responsible for the review and approval of all medical devices in the U.S., with the exception of in vitro diagnostic devices.  Mr. Rhodes had oversight for policy development for all device clinical trials and also served as the CDRH Product Jurisdiction Officer, where he was responsible for CDRH recommendations to the Office of Combination Products regarding the jurisdiction of combination products (Request for Designations) as well as the CDRH recommendations to the Tissue Reference Group on products containing tissues.  He also provided leadership on premarket provisions of the FDA Amendments Act of 2007, including the clinicaltrials.gov databank.

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 premarket applications (including 510(k)s, IDEs, PMAs and HDEs) for plastic and reconstructive surgery devices and neurological implant devices.  During his tenure as branch chief, Mr. Rhodes supervised the review and approval of the first saline-filled and silicone gel-filled breast implants, the first cyanoacrylate tissue adhesives,  the first dural and pulmonary sealants, the first neurological stents, the first hyaluronic acid dermal filler, the first non-viable and the first viable  human cellular product, both for wound care, and numerous surgical meshes and wound care products containing animal source tissue and/or drugs.  Mr. Rhodes also served as acting deputy division director in the Division of Cardiovascular Devices and as acting deputy division director in the Division of Surgical, Orthopedic and Restorative Devices.   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 Investigational Device Exemptions (IDEs) and 6 Premarket Approvals (PMAs).

He has received numerous awards at FDA, including the FDA Engineer of the Year Award, FDA Outstanding Service Award, the Public Health Service Commendation Medal, the CDRH Scientific Achievement Award for Outstanding Intercenter Scientific Collaboration, and the 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), an 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.  Mr. Rhodes said, “BCG has assembled an impressive team of experts to assist firms in bringing innovative medical technologies to market. I am very excited to join BCG and I look forward to using my extensive experience to help companies smoothly navigate the U.S. regulatory process.”

As a Senior Consultant for Medical Devices at Biologics Consulting Group, Mr. Rhodes will utilize his broad technical and regulatory expertise to assist clients in the following areas:

• Short and long term regulatory strategy for medical device technologies, biomaterials, combination products and tissues
• Assisting clients with navigating the regulatory process and developing preclinical and clinical testing plans
• Representing clients in interactions with FDA
• Assisting clients in preparing for FDA meetings and FDA Advisory Panel meetings
• Preparing and assisting in the preparation of  RFDs, Pre-IDEs, IDEs, HDEs, 510(k)s and PMAs
• Providing clients with a comprehensive "FDA style" review of submissions

View Mr. Rhodes Curriculum Vitae...

Page Updated April 13, 2010