Medical device ID
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Patients today face a significant risk that a recalled or defective medical device could be used in their treatment because there is no way for a hospital or physician to quickly and reliably identify such devices. Unique medical device identification (UDI) is the missing link to better ensure patient safety protection.

Regulation and legislation

Studies and reports

  • Results of FDA pilot activities to explore opportunities and challenges with the implementation of a unique deviceĀ identifier system (11/10)
  • ERG final report: Unique identification for medical devices (3/06)
  • The Food and Drug Law Institute/CDRH report onĀ meeting to discuss unique device identification (10/05)
  • ECRI/FDA white paper: Automatic identification of medical devices (8/05)
  • The Food and Drug Law Institute/CDRH report on meeting to discuss unique device identification (4/05)

Related documents:

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