Dr. Elisa Harvey is a Principal Consultant at CardioMed Device Consultants and a former FDA branch chief and regulatory program leader. She brings extensive regulatory and scientific expertise to help medical device manufacturers navigate complex FDA requirements, develop effective preclinical and clinical strategies, and advance innovative technologies toward regulatory approval. Her experience spans complex Class II and Class III devices, with particular expertise in cardiovascular technologies, Investigational Device Exemptions (IDEs), and clinical trial development.
Experience
Dr. Harvey spent more than 10 years at the U.S. Food and Drug Administration (FDA), serving as Chief of the Peripheral Vascular Devices Branch within the Division of Cardiovascular Devices. She oversaw the review of complex medical devices, including peripheral and carotid stents, vena cava filters, aortic stent-grafts, and catheter-based technologies.
She subsequently directed FDA’s Investigational Device Exemption (IDE) and Humanitarian Device Exemption (HDE) programs within the Office of Device Evaluation, overseeing regulatory policy and the agency’s pre-IDE program.
At CardioMed, Dr. Harvey advises manufacturers on preclinical animal study design, feasibility and pivotal clinical trial protocols, FDA Pre-Submission strategies, and regulatory submissions. Her background combines FDA regulatory leadership, scientific research, and clinical veterinary medicine.