Post

Distribution of LOINC Codes for In Vitro Diagnostic Tests by Manufacturers

This guidance addresses the distribution of LOINC codes by IVD test manufacturers to users (clinical laboratories and software vendors). It specifically focuses on the appropriate use of LOINC codes for IVD tests, excluding test results coding for interoperability and UDI requirements.

  1. Review current labeling practices and determine if including LOINC codes would be beneficial
  2. If including LOINC codes:
    • Ensure codes match approved/cleared indications
    • Consider using standardized formats for code distribution
    • Implement quality system controls if codes are incorporated into device output
  3. Establish process for handling individual requests for LOINC codes for uncleared/unapproved uses
  4. Monitor developments in LOINC transmission standards
  5. Consider implementing FDA-recognized consensus standards for LOINC code communication
  6. Document any LOINC code distribution methods and maintain accuracy of provided codes

Key Considerations

Labelling

  • LOINC codes can be voluntarily included in device labeling if accurate and consistent with approved/cleared indications
  • Manufacturers can include LOINC codes in printed labeling or reference to external location
  • LOINC codes should be consistent with FDA-cleared or FDA-approved Indications for Use

Software

  • LOINC codes incorporated directly into devices may be subject to quality system requirements
  • No specific format required for distributing LOINC codes
  • Standardized formats (JSON, XML) are acceptable for code distribution

Other considerations

  • LIVD: LOINC transmission document for IVDs standard

Original guidance

  • Distribution of LOINC Codes for In Vitro Diagnostic Tests by Manufacturers
  • HTML / PDF
  • Issue date: 2018-06-15
  • Last changed date: 2019-02-09
  • Status: FINAL
  • Official FDA topics: Medical Devices, Laboratory Tests, Digital Health, Labeling, IVDs (In Vitro Diagnostic Devices), Biologics
  • ReguVirta summary file ID: 81afdfd4059968b97bbaec27236ca3a7
This post is licensed under CC BY 4.0 by the author.