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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This is a draft guidance. Not for implementation.

  1. Monitor FDA communications for emergency-specific enforcement policies
  2. Assess manufacturer qualifications and experience for compliance
  3. Prepare validation procedures according to emergency-specific guidance
  4. Implement appropriate labeling including FDA non-review disclosure
  5. Maintain compliance with MDR requirements
  6. Consider participation in government evaluation programs
  7. Plan for EUA submission if required
  8. Document risk assessments for test accuracy and safety
  9. Evaluate manufacturing capacity and scaling capabilities
  10. 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

  • 21 CFR Part 803: Medical Device Reporting
  • 21 CFR 10.115(k): Good Guidance Practices

Original guidance

  • Enforcement Policies for Unauthorized Diagnostic Tests During 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: 3ef351712bec03cc8925f71a06942526
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