Unique device identification system. Final rule

Fed Regist. 2013 Sep 24;78(185):58785-828.


The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use. 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. The labeler must submit product information concerning devices to FDA's Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.

MeSH terms

  • Accreditation / legislation & jurisprudence
  • Databases as Topic / legislation & jurisprudence*
  • Databases as Topic / standards
  • Device Approval / legislation & jurisprudence
  • Device Approval / standards
  • Electronic Data Processing / legislation & jurisprudence*
  • Electronic Data Processing / standards
  • Equipment Safety
  • Equipment and Supplies / standards*
  • Humans
  • Patient Safety
  • Product Labeling / legislation & jurisprudence*
  • Product Labeling / standards
  • Product Packaging / legislation & jurisprudence*
  • Product Packaging / standards
  • Terminology as Topic*
  • United States
  • United States Food and Drug Administration / legislation & jurisprudence*
  • United States Food and Drug Administration / standards