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Reliability Requirements for Emergency-Use Auto-Injectors (DRAFT)

This guidance focuses on emergency-use injectors marketed as combination products with emergency-use drugs for treating life-threatening conditions like anaphylaxis, opioid overdose, poisoning, or severe hypoglycemia. It provides recommendations for demonstrating reliability of these devices when submitted under BLA, NDA or ANDA applications.

This is a draft guidance. Not for implementation.

  1. Develop comprehensive reliability specifications targeting 99.999% reliability with 95% confidence
  2. Create detailed fault tree analysis documenting all potential failure modes
  3. Establish test protocols with statistically justified sample sizes
  4. Document preconditioning and use conditions for testing
  5. Implement procedures for maintaining reliability throughout product lifecycle
  6. Create plan for evaluating impact of design/manufacturing changes
  7. Establish quality control procedures and action limits
  8. Prepare reliability report following recommended format
  9. Request early development meetings with FDA to discuss reliability approach
  10. Maintain procedures for investigating failures and implementing corrective actions

Key Considerations

Non-clinical testing

  • Reliability verification testing should be conducted on final finished combination product after appropriate preconditioning and use conditions
  • Sample size for reliability testing should be statistically justified
  • All test failures should undergo root cause analyses linked to fault tree analysis
  • Testing should demonstrate 99.999% reliability with 95% confidence level

Safety

  • Must consider use conditions and preconditioning factors like shipping, aging, storage, vibration, shock, temperature, altitude/pressure effects
  • Need procedures for analyzing quality issues and complaints
  • Must investigate potential causes of malfunctions and identify corrective actions

Other considerations

  • ISO 14971:2007: Medical Devices - Application of risk management to medical devices
  • IEC 61078:2016: Reliability Block Diagrams
  • IEC 61025:2006: Fault Tree Analysis (FTA)
  • ISO 16269-6:2014: Statistical interpretation of data - Determination of statistical tolerance intervals
  • ISO 3534-1:2006: Statistics - Vocabulary and symbols

Original guidance

  • Reliability Requirements for Emergency-Use Auto-Injectors
  • HTML / PDF
  • Issue date: 2020-04-21
  • Last changed date: 2020-04-21
  • Status: DRAFT
  • Official FDA topics: Medical Devices, Combination Products, Drugs, Biologics
  • ReguVirta summary file ID: 2bd04e7e725d54e2bf921614a938938b
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