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.
What You Need to Know? 👇
What are FDA’s current priorities for reviewing monkeypox diagnostic test EUA requests?
FDA prioritizes high-throughput diagnostic tests, tests with home specimen collection, or rapid diagnostic tests from experienced developers with high manufacturing capacity who notify FDA within 30 days of intent to submit.
Can laboratories develop their own monkeypox tests without FDA authorization during the emergency?
Yes, CLIA-certified high-complexity laboratories can offer molecular PCR tests using lesion swabs if appropriately validated and they notify FDA within five business days of offering the test.
What specimen types are acceptable for laboratory-developed monkeypox tests under FDA’s current policy?
Currently, FDA’s enforcement policy only covers lesion swabs for laboratory-developed tests. Other specimen types require EUA authorization or case-by-case discussion with FDA for patient care situations.
Can laboratories modify existing FDA-cleared or authorized monkeypox tests?
Yes, laboratories can modify cleared/authorized tests without new authorization if modifications don’t change indication for use or analyte-specific reagents, validation demonstrates equivalent performance, and FDA receives notification.
What validation requirements does FDA recommend for monkeypox diagnostic tests?
FDA provides voluntary templates with validation recommendations including limit of detection studies and clinical agreement studies. For tests using CDC-identical primers/probes, performance should be consistent with FDA-cleared tests.
Are monkeypox serology tests allowed for clinical use during the emergency?
FDA allows serology tests only in academic medical center laboratories integrated into patient care, with proper validation notification and specific disclaimers that tests cannot diagnose active infection or determine immunity.
What You Need to Do 👇
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