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Immunological Testing for Medical Devices: Evaluation and Assessment of Adverse Effects

This guidance provides a systematic approach for evaluating potential adverse immunological effects of medical devices and constituent materials. It focuses on immunotoxicity testing and helps determine when such testing is needed and what specific tests should be performed. The guidance aims to optimize testing requirements while ensuring adequate safety evaluation.

  1. Use the flow chart to determine if immunotoxicity testing is needed
  2. Review existing data and history of use before conducting new tests
  3. Use Tables 1-3 sequentially to determine appropriate testing when needed:
    • Table 1: Identify potential immunotoxic effects based on device contact and duration
    • Table 2: Determine critical immune responses to evaluate
    • Table 3: Select appropriate tests based on identified responses
  4. Focus on functional assays over soluble mediators and phenotyping
  5. Ensure statistical validity in study design
  6. Consider consulting with FDA immunologists/immunotoxicologists when needed
  7. Document and evaluate any signs of immune system dysfunction
  8. Include immune function studies in clinical trials if preclinical testing shows significant immunotoxicity

Key Considerations

Non-clinical testing

  • Use appropriate animal models as they may provide a more accurate picture of immune system competence
  • Ensure sound statistical basis in study design (p<0.05 level)
  • Mimic intended use regarding exposure route, dose and duration
  • Consider host resistance assays to bacteria, viruses and tumors

Biocompatibility

  • Evaluate five main immunotoxic effects:
    • Hypersensitivity (Type I and IV reactions)
    • Chronic inflammation
    • Immunosuppression
    • Immunostimulation
    • Autoimmunity
  • Consider material type (plastics, metals, ceramics, biological materials)
  • Consider duration of body contact (limited, prolonged, permanent)

Safety

  • Monitor for signs of immune system dysfunction
  • Document any signs of illness (allergy, skin rash, urticaria, edema, lymphadenopathy)
  • Evaluate functional assays as they provide more direct measure of immune system activity

Other considerations

  • ISO 10993: Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing

Original guidance

  • Immunological Testing for Medical Devices: Evaluation and Assessment of Adverse Effects
  • HTML
  • Issue date: 1999-05-05
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 487d5fa274d43e4a3f01df2e579200ec
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