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Policy for Laboratory Tests Used in Response to Chemical, Biological, Radiological, or Nuclear Public Health Emergencies (DRAFT)

This guidance applies to immediate response tests that are: - For detecting/diagnosing serious or life-threatening conditions from newly identified or unusual CBRN agents - Needed for immediate response when no adequate approved alternatives exist - Intended to support government public health response during emergent situations - Not including home specimen collection or at-home tests

This is a draft guidance. Not for implementation.

  1. Verify eligibility as qualified laboratory manufacturer (CLIA certification, high complexity testing capability)
  2. Complete required validation studies:
    • Clinical evaluation
    • Analytical studies (LOD, inclusivity, cross-reactivity)
  3. Prepare notification package for FDA including:
    • Test and laboratory information
    • Validation data
    • Compliance status
    • Public information link
  4. Develop compliant labeling and test reports
  5. Establish process for:
    • Public posting of validation/performance data
    • Reporting to public health agencies
    • Medical device reporting
    • EUA submission if declaration occurs
  6. Monitor timeline for either resolution or FDA declaration (12-month window)
  7. Maintain documentation of all validation, notifications and reporting

Key Considerations

Clinical testing

  • Clinical evaluation of at least 30 positive and 30 negative clinical samples (or synthetic specimens if not available)
  • Additional validation with natural clinical specimens when feasible

Non-clinical testing

  • Limit of detection (analytical sensitivity)
  • Inclusivity (analytical reactivity)
  • Cross-reactivity (analytical specificity)

Labelling

  • Must be labeled for prescription use only
  • Test reports must disclose that the test is for immediate public health response and not FDA authorized
  • No false/misleading claims about FDA review or authorization
  • Summary validation and performance information must be publicly available

Safety

  • Medical Device Reporting (MDR) requirements under 21 CFR Part 803 apply

Other considerations

  • 21 CFR Part 803: Medical Device Reporting

Original guidance

  • Policy for Laboratory Tests Used in Response to Chemical, Biological, Radiological, or Nuclear Public Health Emergencies
  • HTML / PDF
  • Issue date: 2024-05-06
  • Last changed date: 2024-04-29
  • Status: DRAFT
  • Official FDA topics: Medical Devices, Outbreak, IVDs (In Vitro Diagnostic Devices)
  • ReguVirta summary file ID: ff665bc763206d74c8a9406279bf0720
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