The U.S. Food and Drug Administration (FDA) has issued guidance to help industry, particularly small businesses, label their medical devices in conformity with a September 2013 rule that establishes a unique device identification (UDI) system. The rule requires the labels and device packages of medical devices distributed in the United States to include a UDI, unless the agency grants an exception or alternative to the rule’s UDI label requirements. Among other matters, the system is intended to improve the effectiveness of medical device recalls, allow rapid identification of a device to help correct adverse event reports quickly, give medical providers information about the device to reduce medical errors, and standardize the way device use is documented, “leading to a more robust postmarket surveillance system which can be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.” The guidance also includes compliance dates for UDI implementation; they start for certain devices on September 24, 2014, and will require full compliance by 2020.