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

This is a draft guidance. Not for implementation.

What You Need to Know? 👇

What is the scope of FDA’s enforcement policy for immediate response tests during emergent situations?

The policy applies to tests detecting serious/life-threatening diseases from CBRN agents during emergent situations, when no adequate approved alternatives exist, and needed for coordinated public health response. It excludes home collection/at-home tests.

Which laboratories can offer immediate response tests under this enforcement policy?

CLIA-certified laboratories performing high complexity testing, including USG laboratories, state/local public health labs, labs with USG agreements, CDC labs, CDC Laboratory Response Network members, or labs under CDC agreements.

What validation requirements must be met before offering an immediate response test?

Tests require clinical evaluation of 30 positive/30 negative samples (or contrived specimens), limit of detection studies, inclusivity testing, and cross-reactivity analysis. Summary validation information must be publicly available.

How long can laboratories offer immediate response tests without FDA authorization?

Generally up to 12 months from emergent situation start. If a Section 564 declaration occurs, labs have 21 days to submit EUA requests and can continue while FDA reviews.

What notification requirements exist when offering immediate response tests?

Labs must email CDRH-EUA-Templates@fda.hhs.gov before/during testing initiation, including disease rationale, contact information, lab details, test methodology, regulatory standing, and link to public validation information.

What transparency requirements apply to immediate response test reports?

Test reports must prominently disclose the test was manufactured for immediate public health response during emergent situations, hasn’t been FDA reviewed/authorized, and identify the specific disease/condition being detected.

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What You Need to Do 👇

Recommended Actions

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

• 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

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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

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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 ID: ff665bc763206d74c8a9406279bf0720