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COVID-19 Testing Policy: Validation Requirements and Recommendations for Diagnostic and Serology Tests

This guidance applies to diagnostic (molecular and antigen) and serology tests for COVID-19. It outlines policies and recommendations to facilitate the availability of tests that FDA believes will be most beneficial at the current stage of the public health emergency. The guidance is limited to high-complexity CLIA-certified laboratories unless an EUA specifically authorizes additional testing environments.

  1. Determine if test falls within FDA’s current review priorities for EUA
  2. For new tests:
    • Consider traditional premarket pathways if not within EUA priorities
    • Follow appropriate validation templates and requirements
    • Make performance data publicly available
    • Ensure proper labeling and result reporting
  3. For modified tests:
    • Validate modifications appropriately
    • Document equivalence to authorized test
    • Update labeling to reflect modifications
    • Consider submitting data to original test developer
  4. For all tests:
    • Implement medical device reporting
    • Report results to public health authorities
    • Maintain documentation of validation
    • Monitor FDA communications for policy updates
  5. Contact FDA for guidance if unclear about requirements or considering alternative approaches

Key Considerations

Clinical testing

  • Tests should be validated using clinical specimens and appropriate comparator tests prior to use
  • False results can negatively impact individual patients and have broad public health impact
  • Independent evaluation by NIH/NCI required for certain serology tests prior to authorization

Non-clinical testing

  • Analytical validation required following FDA templates and recommendations
  • Lower level of evidence accepted for EUA compared to traditional premarket pathways
  • Alternative validation approaches can be discussed with FDA

Labelling

  • Test reports must disclose if test has not been FDA reviewed
  • Instructions for use and performance data should be publicly available
  • Serology test reports must include specific limitations and interpretation guidance
  • Modified tests must prominently disclose modifications from authorized version

Other considerations

  • CLIA: Clinical Laboratory Improvement Amendments

Original guidance

  • COVID-19 Testing Policy: Validation Requirements and Recommendations for Diagnostic and Serology Tests
  • HTML / PDF
  • Issue date: 2023-01-12
  • Last changed date: 2024-12-30
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, IVDs (In Vitro Diagnostic Devices), Immunology & Microbiology, Coronavirus, CLIA (Clinical Laboratory Improvement Amendments)
  • ReguVirta summary file ID: ead58ee25c4317d6a4dffb4098836ff5
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