On June 1 and 2, 2009, the FDA is holding a public workshop on the use of computational modeling in the design, development, and evaluation of cardiovascular medical devices. Issues to be discussed may include: multi-scale modeling; imaging for cardiovascular device modeling; physiologic input data for cardiovascular device modeling; device-specific issues related to modeling, including a focus on heart valves, drug-eluting and bare metal stents, endovascular stents, cardiac rhythm management, and mechanical and circulatory support devices; and regulatory issues with implementation of computer modeling.