Post

Unique Device Identifier (UDI) Form and Content Requirements

This guidance describes the requirements and recommendations for the form and content of Unique Device Identifiers (UDI), including the two forms of UDI presentation, content clarification, use of data delimiters, and recommended data order. It applies to medical device labelers and FDA-accredited issuing agencies but does not apply to Universal Product Codes (UPCs).

  1. Implement both plain text and AIDC forms of UDI on device labels and packages
  2. Ensure proper use of data delimiters to distinguish UDI elements
  3. Follow recommended order of information in plain text form
  4. Test print quality of barcodes using recommended standards
  5. Verify AIDC forms can be reliably read at points of use
  6. Consult FDA-accredited issuing agency for specific format guidelines
  7. For software devices, implement appropriate UDI display mechanisms
  8. Ensure clear distinction between UDI and non-UDI elements in labeling
  9. Document compliance with UDI system requirements
  10. Maintain proper controls over UDI assignment and use

Key Considerations

Software

  • Stand-alone software not distributed in packaged form must display UDI in plain text at startup or through menu command
  • Software version must be conveyed in the Production Identifier (PI)
  • Stand-alone software in packaged form must display UDI at startup/menu and have UDI on package in both plain text and AIDC forms

Labelling

  • UDI must be presented in two forms: easily readable plain-text and AIDC technology
  • Plain text must include Device Identifier (DI) and Production Identifier (PI) if applicable
  • Data delimiters must be included to identify specific data elements
  • For multiple AIDC forms, only one plain text form is required
  • AIDC presence must be disclosed if not visually evident
  • Recommended order: DI first, followed by PI, then any non-UDI elements

Other considerations

  • ISO/IEC 15459-2: Information technology - Unique identifiers - Part 2: Registration procedures
  • ISO/IEC 15459-4: Information technology - Unique identifiers - Part 4: Individual items
  • ISO/IEC 15459-6: Information technology - Unique identifiers - Part 6: Unique identifier for product groupings
  • ISO/IEC 15416: Bar code print quality test specification - Linear symbols
  • ISO/IEC 15415: Bar code symbol print quality test specification - Two-dimensional symbols
  • ISO/IEC TR 29158: Direct Part Mark Quality Guideline

Original guidance

  • Unique Device Identifier (UDI) Form and Content Requirements
  • HTML / PDF
  • Issue date: 2021-07-07
  • Last changed date: 2021-07-15
  • Status: FINAL
  • Official FDA topics: Medical Devices, UDI, Labeling, Biologics
  • ReguVirta summary file ID: a1cfaae2ef9e13f2d2edd76254565039
This post is licensed under CC BY 4.0 by the author.