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  • Feature ArticlesFeature Articles

    FDA Acts on Long-Delayed UDI Rule

    On 2 July 2012, the US Food and Drug Administration (FDA) published the eagerly awaited proposed rule requiring a unique device identifier (UDI) be placed on the label and packaging of marketed medical devices. 1 The UDI rule was mandated under the Food and Drug Administration Amendments Act of 2007, but has been delayed numerous times. There has been an ongoing debate about the list of mandatory information elements and the cost and merits of potential bar-code syst...