Meeting of FDA and international standards and testing protocols constitutes an integral part of getting a medical device approved. In a global setting, region specific requirements mandated by the various regulatory bodies often tend to be confusing. This session is aimed at bringing together expertise from various cardiovascular fields like catheters, drug eluting stents, heart valves, vena cava filters, etc. to help gain a better understanding of the "real-world" development/regulatory process. It will include not only the regulatory process as a part of the discussion but a bulk of the discussion would also involve non-clinical testing for these various devices necessary to satisfy the regulatory bodies.