The Official Comment of AHRMM to the United States Department of Health and Human Services Food and Drug Administration (FDA) regarding Unique Device Identification for Medical Devices Docket No. FDA-2011-N-0090
AHRMM comments to the FDA regarding an amendment to the UDI proposed rule to address the UDI implementation time frame required by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA).
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This is an executive summary of the case study published in the
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