Enforcement Policies for Unauthorized Diagnostic Tests During Public Health Emergencies (DRAFT)
This guidance describes FDA's approach to issuing enforcement policies for unapproved diagnostic tests during declared emergencies under section 564 of the FD&C Act. It outlines the factors FDA considers when deciding whether to allow certain unapproved tests or unapproved uses of approved tests to help expand testing availability during emergencies.
This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What is the purpose of FDA’s enforcement policies for unapproved tests during emergencies?
FDA’s enforcement policies help expand access to diagnostic tests during declared emergencies under Section 564 when authorized tests are insufficient to meet demand, while maintaining appropriate safety standards.
When does FDA consider issuing enforcement policies for unapproved diagnostic tests?
FDA considers enforcement policies during Section 564 declared emergencies when there’s insufficient testing capacity, limited alternatives, time-sensitive needs, and appropriate risk mitigations are available to address false results.
What factors does FDA evaluate before implementing test enforcement policies during emergencies?
FDA evaluates four key factors: testing needs and urgency, risks of unauthorized tests, availability of approved alternatives, and mitigations to address false result risks including manufacturer experience.
How long do FDA enforcement policies for emergency diagnostic tests typically remain in effect?
FDA establishes initial periods for enforcement policies and periodically reviews them, adjusting duration as needed. During COVID-19, FDA issued six updates reflecting changing needs and test landscapes.
What validation requirements apply to tests under FDA emergency enforcement policies?
Tests must be validated according to FDA recommendations specific to each emergency. Manufacturers should submit validation data, proper labeling, and EUA requests within reasonable timeframes as specified.
Can FDA still take enforcement action against test manufacturers during emergency enforcement policies?
Yes, FDA retains full discretion to pursue enforcement actions for violations of FD&C Act, PHS Act, or regulations, and will take action when appropriate for public health protection.
What You Need to Do 👇
Recommended Actions
- Monitor FDA communications for emergency-specific enforcement policies
- Assess manufacturer qualifications and experience for compliance
- Prepare validation procedures according to emergency-specific guidance
- Implement appropriate labeling including FDA non-review disclosure
- Maintain compliance with MDR requirements
- Consider participation in government evaluation programs
- Plan for EUA submission if required
- Document risk assessments for test accuracy and safety
- Evaluate manufacturing capacity and scaling capabilities
- Monitor enforcement policy updates and changes during emergency period
Key Considerations
Non-clinical testing
- Validation procedures may be required as specified in emergency-specific guidance
- Test performance expectations to be outlined in specific enforcement policies
Labelling
- Public disclosure required stating tests have not been reviewed by FDA
- Specific labeling statements may be required as outlined in emergency-specific guidance
Safety
- Medical Device Reporting (MDR) requirements under 21 CFR Part 803 remain applicable
- Risk assessment of unauthorized and potentially inaccurate tests required
- Consideration of sample collection risks and test component risks
Other considerations
- Manufacturer experience and compliance history evaluated
- Possible participation in government evaluation programs (e.g., NIH RADx Tech ITAP)
- Submission of EUA request within reasonable timeframe may be required
- Manufacturing capacity and scaling capabilities assessed
- Test turnaround time considerations
- Alternative test availability evaluation
Relevant Guidances 🔗
- Emergency Use Authorization of Medical Products: Requirements and Procedures for Unapproved Products and Uses
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
Related references and norms 📂
- 21 CFR Part 803: Medical Device Reporting
- 21 CFR 10.115(k): Good Guidance Practices