Guidance for New Medical Device Identifier

GS1 Healthcare US has issued guidance for using the standards when implementing the new Unique Device Identification requirements for medical devices. In general, a final rule published in September 2013 requires the label on medical devices to include a UDI, with some exceptions or alternative placement depending on characteristics of a device. The guidance from GS1 Healthcare comes as the first device-labeling compliance date of Sept. 24, 2014, looms, with four other compliance deadlines between then and September 24, 2020. The guidance is available at www.gs1us.org/industries/healthcare/gs1-healthcare-us/fda-udi/udi-guide

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