FDA's Unique Device Identification System Final Rule | IVT

FDA’s stated purpose for this Final Rule is “to establish a system to adequately identify devices through distribution and use. This 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 (GUDID) 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...