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.
Recommended Actions
- Determine if animal study is needed based on risk analysis and available alternatives
- 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
- Consider using Q-Submission process to:
- Obtain feedback on animal model selection
- Discuss alternatives to animal testing
- Clarify specific study design elements
- 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
- Study personnel must have appropriate qualifications and training
- Testing facility must meet requirements for animal housing and care
- Records and reports must comply with GLP requirements
- Quality Assurance Unit oversight is required
- Raw data must be retained and available for FDA review
Relevant Guidances
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Biological Evaluation of Medical Devices Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
Related references and norms
- 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
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