FDA issues proposed identifier rule

The Food and Drug Administration (FDA) issued a proposed rule implementing a 2007 statutory requirement to establish a unique device identification (UDI) system for medical devices. The rule would phase in a requirement that many device labels and packages include a unique device identifier based on international standards. The FDA said it would accept comments on the rule for 120 days after publication in the Federal Register. The American Hospital Association has supported development of a UDI and plans to keep its members updated.

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