In September 2009, the United States Food & Drug Administration (FDA) commissioned a report from the Institute of Medicine (IOM) on the current 510(k) pre-market approval process, the most common pathway to market for lower-risk medical devices. The FDA undertook the assessment in response to concerns raised by various stakeholders in an effort to determine what, if any, changes should be made to improve the program and update it so that it adequately addresses the level of current device complexity and today’s marketplace.