Cardiovascular medical devices: Regulatory science research overview in the office of science and engineering laboratories (OSEL) at the food and drug administration (FDA)

Abstract

The Cardiovascular Research Program in OSEL at the FDA consists of a diverse group of engineers and scientists who seek to drive innovation in cardiovascular device technology through development and standardization of pre-clinical test methods using in vitro, in vivo, and in silico models. The goal is to improve the pre- and post-market regulatory review processes and to accelerate patient access to safe and effective cardiovascular medical devices (e.g., heart valves, ventricular assist devices, cardiopulmonary bypass and cardiac mapping systems, ablation catheters, pacemakers, defibrillators, cardiac occluders, etc).