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Full Description

ADA 1081-2019: The FDA has issued a rule to establish a system to adequately identify devices through distribution. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement.
 

Document History

  1. ADA 1081-2019

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    FDA's Unique Device Identifiction (UDI) Program for Dental Devices and Biologics Regulated as Medical Devices - Technical Report

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  2. ADA 1081-2015


    FDA's Unique Device Identifiction (UDI) Program for Dental Devices and Biologics Regulated as Medical Devices - Technical Report

    • Historical Version