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Unique Device Identification System: Implementation and Compliance Requirements

This guidance provides clarification on key provisions of the UDI Rule, which establishes a unique device identification system for medical devices. It covers UDI basics, placement requirements, GUDID database requirements, direct marking requirements, and various exceptions/alternatives.

  1. Determine device classification and applicable compliance dates
  2. Select FDA-accredited issuing agency for UDI assignment
  3. Implement proper date format on labels
  4. Establish process for assigning new DIs when device changes occur
  5. Request GUDID account and prepare for data submission
  6. Evaluate need for direct marking based on device intended use
  7. Review exceptions and alternatives applicable to your devices
  8. Implement UDI in both plain-text and AIDC formats
  9. Update quality system procedures to incorporate UDI requirements
  10. Train relevant personnel on UDI system requirements and procedures

Key Considerations

Software

  • Stand-alone software must provide UDI through plain-text statement when started or through menu command
  • Software updates require new Device Identifier (DI) only if resulting in new version/model
  • Packaged software must follow standard UDI labeling requirements

Labelling

  • UDI must appear in both plain-text and AIDC format
  • Date format must be YYYY-MM-DD
  • Each package configuration requires unique DI
  • Label must indicate presence of non-visible AIDC technology
  • UDI placement required on device label and packages

Other considerations

  • 21 CFR 801: Labeling
  • 21 CFR 830: Unique Device Identification
  • 21 CFR 820: Quality System Regulation

Original guidance

  • Unique Device Identification System: Implementation and Compliance Requirements
  • HTML / PDF
  • Issue date: 2014-08-20
  • Last changed date: 2021-07-15
  • Status: FINAL
  • Official FDA topics: Medical Devices, UDI, Labeling, Biologics
  • ReguVirta summary file ID: 486c4eefa35d2b05ce6a2b80825a21f6
This post is licensed under CC BY 4.0 by the author.