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Validation of In Vitro Diagnostic Tests for Emerging Pathogens During Public Health Emergencies (DRAFT)

This guidance describes recommendations for validation of certain in vitro diagnostic (IVD) devices for emerging pathogens during a declared emergency under section 564. It applies to: - Diagnostic tests intended to detect newly identified, previously unknown, or unusual pathogens to aid in diagnosis of serious/life-threatening infectious diseases - Tests detecting known pathogens that aid in diagnosing newly identified/unusual clinical presentations - Tests submitted for pre-EUA, EUA request, or offered under enforcement discretion policy - All stages of an outbreak, with considerations for early stages when validation materials may be limited

This is a draft guidance. Not for implementation.

  1. Determine test type and applicable validation requirements
  2. Design validation studies based on test type and intended use
  3. Conduct clinical performance evaluation with appropriate sample size
  4. Perform required analytical validation studies
  5. Complete usability/human factors testing if applicable
  6. Validate software and assess cybersecurity if needed
  7. Develop clear labeling at appropriate reading level
  8. Document all validation results thoroughly
  9. Consider predetermined change control plans for future modifications
  10. Monitor emerging variants/mutations that may affect performance
  11. Implement appropriate quality control measures
  12. Prepare comprehensive EUA submission package

Key Considerations

Clinical testing

  • Minimum 30 positive and 30 negative specimens recommended
  • Use highly sensitive comparator method when available
  • Early outbreak: contrived samples acceptable with minimum 30 positive samples (20 near LoD)
  • Asymptomatic use: 20 positives/100 negatives recommended
  • Document time from symptom onset for symptomatic patients

Non-clinical testing

  • Limit of Detection (LoD) studies required
  • Fresh vs frozen specimen comparison if using frozen samples
  • Specimen stability studies at recommended storage conditions
  • Reagent stability studies for shipping/storage conditions
  • Analytical equivalency studies for optional components/workflows

Human Factors

  • Usability studies for home use/POC tests
  • User comprehension studies for lay users
  • Quick Reference Instructions at 7th grade reading level
  • Flex studies to evaluate robustness under stress conditions

Software

  • Validation required for new software functions
  • Verify inputs/outputs meet requirements
  • Risk assessment and defect mitigation
  • Cybersecurity evaluation for external interfaces

Cybersecurity

  • Evaluate wired/wireless communication interfaces
  • Ensure user/patient safety in intended environment
  • Address data security and privacy

Labelling

  • Instructions for use at 7th grade reading level
  • Quick Reference Instructions with diagrams
  • Clear result interpretation guidance
  • Safety warnings and precautions

Safety

  • Basic safety evaluation for new instruments
  • Electrical, fire, mechanical hazard assessment
  • EMC testing for electrical/electronic systems

Other considerations

  • IEC 60601-1: Medical electrical equipment - General requirements for basic safety and essential performance
  • IEC 61326-1: Electrical equipment for measurement, control and laboratory use - EMC requirements
  • CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures
  • CLSI EP25-A: Evaluation of Stability of In Vitro Diagnostic Reagents
  • CLSI EP07: Interference Testing in Clinical Chemistry

Original guidance

  • Validation of In Vitro Diagnostic Tests for Emerging Pathogens During Public Health Emergencies
  • HTML / PDF
  • Issue date: 2025-01-06
  • Last changed date: 2025-01-06
  • Status: DRAFT
  • Official FDA topics: Medical Devices, IVDs (In Vitro Diagnostic Devices)
  • ReguVirta summary file ID: 4e402b2e82713dcd263a1d7dfdbeecfd
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