In a follow-up to a final rule issued in September 2013, requiring that most medical devices distributed in the United States carry a unique device identifier ("UDI"), FDA has issued a small entity compliance guidance on the Unique Device Identification System. The guidance instructs small businesses on how to label their devices in order to comply with the rule. Under the rule, every UDI must be presented in two forms: plain text and using special data capture technology. Class I devices, according to the guidance, will be permitted to use a universal product code as the UDI on the device label and package. The guidance features key definitions, compliance dates, and formatting requirements related to the UDI system. FDA concurrently issued Unique Device Identification System: Frequently Asked Questions, Vol. 1 Guidance for Industry and Food and Drug Administration Staff, which summarizes key aspects of the UDI final rule and addresses UDI basics, UDI placement, the Global Unique Device Identifier Database, and direct marking, as well as exceptions, alternatives, and exemptions.
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