Department of Health and Human Services, Food and Drug Administration: Unique Device Identification System
GAO-14-130R: Oct 23, 2013
GAO reviewed the Department of Health and Human Services, Food and Drug Administration's (FDA) new rule on its unique device identification system. GAO found that (1) the final rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA's Global Unique Device Identification Database, unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture technology. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use and (2) FDA complied with the applicable requirements in promulgating the rule.