The Food and Drug Administration recently issued a final rule requiring most medical devices distributed in the United States to carry a unique device identifier (UDI) within seven years. Class III (high-risk) devices must comply by Sept. 24, 2014, and Class I devices by Sept. 24, 2020. Devices intended for reuse eventually must bear a permanent UDI marking. A draft guidance was published on Sept. 24.
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FDA issues final unique medical device identifier rule
November 2013 Checklist
November 1, 2013