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

What You Need to Know? 👇

What are FDA’s current priorities for reviewing COVID-19 test EUA requests?

FDA prioritizes EUA requests from experienced developers for diagnostic tests with significant public health benefit (innovative technology) or fulfilling unmet needs (new variant detection), plus tests from/supported by U.S. government stakeholders like BARDA or NIH RADx.

Can laboratories modify EUA-authorized COVID-19 tests without FDA approval?

High-complexity CLIA-certified laboratories can modify authorized molecular diagnostic tests without FDA notification if modifications don’t change indication for use or analyte specific reagents, the laboratory validates equivalent performance, and use remains within that laboratory only.

What enforcement policies apply to COVID-19 tests distributed during FDA review?

FDA doesn’t object to continued distribution of tests on notification lists or LDTs submitted before November 15, 2021, during EUA review. However, developers must cease distribution within 15 days if FDA declines authorization or identifies significant problems.

Are traditional premarket pathways available for COVID-19 tests outside FDA’s EUA priorities?

Yes, FDA encourages developers of tests outside current EUA review priorities to pursue traditional premarket review pathways (510(k), PMA). These pathways remain available and may be more appropriate for many COVID-19 test developers at this pandemic stage.

What validation requirements apply to COVID-19 tests seeking authorization?

All tests must be validated using clinical specimens and appropriate comparators before use. FDA accepts lower evidence levels for EUA than traditional pathways. EUA templates provide validation recommendations, though traditional pathways may require additional studies.

How long will these COVID-19 testing policies remain in effect?

The policies are intended to remain effective only for the duration of the HHS Secretary’s February 4, 2020 declaration under section 564 of the FD&C Act, which justified emergency use authorization of COVID-19 diagnostics.

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What You Need to Do 👇

Recommended Actions

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

• 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

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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

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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 ID: ead58ee25c4317d6a4dffb4098836ff5