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.
Recommended Actions
- Determine if test falls within FDA’s current review priorities for EUA
- 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
- For modified tests:
- Validate modifications appropriately
- Document equivalence to authorized test
- Update labeling to reflect modifications
- Consider submitting data to original test developer
- For all tests:
- Implement medical device reporting
- Report results to public health authorities
- Maintain documentation of validation
- Monitor FDA communications for policy updates
- 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
- FDA prioritizes review of EUA requests from experienced developers for innovative or unmet needs
- States/territories previously authorized to oversee laboratory testing can continue
- Modifications to authorized tests have specific validation requirements
- Medical device reporting requirements apply
- Results must be reported to appropriate public health authorities
Relevant Guidances
- Impact of Viral Mutations on SARS-CoV-2 Tests: Evaluation and Monitoring Recommendations
- Policy for Laboratory Tests Used in Response to Chemical, Biological, Radiological, or Nuclear Public Health Emergencies (Draft)
- Research Use Only and Investigational Use Only In Vitro Diagnostic Products - Labeling and Distribution Requirements
- In Vitro Diagnostic Device Studies Exempt from Investigational Device Exemption Requirements
Related references and norms
- 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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