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Animal Testing for Medical Device Safety and Performance Evaluation

This guidance provides recommendations for designing, conducting, and reporting animal studies intended to evaluate medical device safety, including performance and handling, to support premarket submissions to FDA. It applies to devices intended for human use and covers studies that must comply with Good Laboratory Practice (GLP) Regulations.

  1. Determine if animal study is needed based on risk analysis and available alternatives
  2. If animal study is needed:
    • Submit Pre-Submission to FDA for feedback on study design
    • Select appropriate testing facility compliant with GLP
    • Develop detailed protocol addressing study objectives and acceptance criteria
    • Ensure appropriate personnel qualifications and training
    • Use device in final finished form when possible
    • Document all procedures, observations and results according to GLP requirements
    • Include comprehensive pathology evaluation
    • Prepare detailed final report with all required elements
  3. Consider using Q-Submission process to:
    • Obtain feedback on animal model selection
    • Discuss alternatives to animal testing
    • Clarify specific study design elements
  4. Ensure final submission includes:
    • Executive summary of all animal studies
    • Complete final reports with required GLP elements
    • Raw data and supplementary reports
    • Justification for animal model selection
    • Description of device iterations and design changes

Key Considerations

Non-clinical testing

  • Animal studies must comply with GLP Regulations when intended to support device safety in premarket submissions
  • Study design should simulate clinical setting and reflect intended use
  • Sample size should be sufficient to meet study objectives
  • Appropriate controls should be included
  • Study should use device in its final finished form whenever possible

Biocompatibility

  • Local and systemic effects should be evaluated
  • Tissue responses should be characterized through histopathology
  • Post-mortem assessment methods should be used to evaluate tissue responses

Safety

  • Study objectives should address identified risks from risk analysis
  • Device performance and handling parameters essential to safety should be evaluated
  • Monitoring of animals during and after procedures is required
  • Adverse events must be documented and assessed for causation
  • Comprehensive necropsy should be performed by qualified pathologist

Other considerations

  • ISO 14971: Medical devices – Application of risk management to medical devices
  • ANSI/AAMI/ISO 10993-6: Biological Evaluation of Medical Devices, Part 6: Tests for Local Effects after Implantation

Original guidance

  • Animal Testing for Medical Device Safety and Performance Evaluation
  • HTML / PDF
  • Issue date: 2023-03-28
  • Last changed date: 2023-03-27
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket Approval (PMA), 510(k), Premarket, HUD/HDE, Investigational Device Exemption (IDE)
  • ReguVirta summary file ID: 56a057aa22a52d49f2acd3fc3b228e35
This post is licensed under CC BY 4.0 by the author.