Prior to joining MCRA in 2007, Ms. Rhodes served as a reviewer in the FDA orthopedic devices branch for 17 years, and advised firms and inventors as they developed testing and clinical protocols for new orthopedic technologies. While at FDA she served as a lead reviewer for over 400 510(k)s, 25 IDEs, and 10 PMAs; devices include hips, knees, ankles, shoulders, elbows, wrists, toes, suture anchors, spinal systems, and fracture fixation systems. Ms. Rhodes served as an Agency expert for total ankle devices.
Ms. Rhodes holds a Bachelor of Science degree in Biomedical Engineering from Duke University.
Ms. Rhodes works closely with the Clinical, Quality Assurance, and Reimbursement specialists at MCRA to perform technology assessment and due diligence on firms buying or selling orthopedic technologies.
Overview
Ms. Rhodes is responsible for regulatory affairs relevant to general orthopedic devices (hip, knee, small bone, trauma, etc.) for MCRA's clients, assisting clients with writing regulatory submissions, identifying the appropriate regulatory pathway for new technologies and indications, developing regulatory, clinical, and testing strategies for new devices, and assisting clients with response and appeal strategies for 510(k), IDE, PMA, and de novo submissions.