Policy for Monkeypox Testing During the Public Health Emergency
This guidance outlines FDA's policies and recommendations for expanding testing availability for monkeypox or other non-variola orthopoxviruses during the public health emergency. It applies to certain laboratories certified under CLIA for high-complexity testing and commercial manufacturers developing monkeypox tests.
Recommended Actions
- Determine if test falls under enforcement discretion policy scope
- Validate test according to FDA recommendations
- Submit notification to FDA within required timeframe
- Implement appropriate result reporting and labeling
- Monitor FDA communications for policy updates
- Maintain compliance with MDR requirements
- Consider submitting EUA request if test is outside enforcement discretion
- Collaborate with original test developer for modifications
- Post validation data on website for modified tests
- Notify FDA of any significant problems or concerns
Key Considerations
Clinical testing
- Tests must be appropriately validated before use
- Clinical validation initially recommended with contrived specimens
- Clinical samples may be required when more widely available
Non-clinical testing
- Limit of Detection (LoD) evaluation required
- Performance should be consistent with FDA-cleared CDC test for tests using identical primers/probes
Labelling
- Test reports must disclose if test has not been FDA reviewed
- For serology tests, specific disclaimers required about limitations
- No false/misleading statements about FDA review/authorization
Other considerations
- Notification to FDA required within 5 business days of test offering
- High-throughput, home specimen collection, or rapid diagnostic tests from experienced developers will be prioritized
- Only PCR technology using lesion swabs allowed under enforcement discretion
- Modifications to FDA-cleared/authorized tests must not change indication for use or analyte specific reagents
- Results must be reported to appropriate public health agencies
Relevant Guidances
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
- In Vitro Diagnostic Devices for Detection and Differentiation of Influenza Viruses - Performance Testing and Validation Requirements
- In Vitro Diagnostic Devices for Detection of Antibodies to Borrelia burgdorferi - Performance Characteristics and Testing Requirements
- 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
- 21 CFR Part 803: Medical Device Reporting
- 21 CFR 866.3315: Non-variola Orthopoxvirus serological reagents
Original guidance
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