With the release of the UDI rule from the FDA in September of 2013, the regulatory landscape has changed for manufacturers marketing products in the United States, and device and diagnostic corporations have initiated UDI process implementation programs to meet compliance with new product identification and tracking requirements. Furthermore, geographies in the international setting such as the European Union and China are currently developing UDI regulations, similar to that of the FDA but also including market-specific rules for which the industry must proactively prepare for. This conference program will shed light on grey areas in UDI implementation in the US and internationally, and clarify compliance means via practical real-life case study presentations from the industry and insight from regulators and standard development organizations.