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This is a draft guidance. Not for implementation.
Recommended Actions
- Verify eligibility as qualified laboratory manufacturer (CLIA certification, high complexity testing capability)
- Complete required validation studies:
- Clinical evaluation
- Analytical studies (LOD, inclusivity, cross-reactivity)
- Prepare notification package for FDA including:
- Test and laboratory information
- Validation data
- Compliance status
- Public information link
- Develop compliant labeling and test reports
- Establish process for:
- Public posting of validation/performance data
- Reporting to public health agencies
- Medical device reporting
- EUA submission if declaration occurs
- Monitor timeline for either resolution or FDA declaration (12-month window)
- 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
- Limited to CLIA-certified labs performing high complexity testing
- Must notify FDA prior to or concurrent with test offering
- Must notify appropriate public health agencies of test results
- 12-month timeframe expected for either resolution or FDA declaration
- Must submit EUA request within 21 days if declaration is made
Relevant Guidances
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Medical Device Reporting Requirements for User Facilities
Related references and norms
- 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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