Animal Testing for Medical Device Safety and Performance Evaluation

What You Need to Know? 👇

What are the key requirements for animal studies supporting medical device premarket submissions?

Animal studies must comply with Good Laboratory Practice (GLP) regulations under 21 CFR Part 58, include qualified personnel with appropriate credentials, follow written protocols, and demonstrate device safety including performance and handling characteristics in living systems.

When should sponsors consider conducting animal studies for medical device development?

Conduct animal studies when risk analysis identifies safety concerns that cannot be adequately addressed through benchtop testing or alternative methods. Consider after completing nonclinical bench testing with the device in final finished form.

What personnel qualifications are required for conducting GLP animal studies?

A qualified study director with relevant education and experience must oversee the study. Teams should include skilled veterinary staff, an independent Quality Assurance Unit, and may benefit from specialists in pathology, radiology, surgery, and laboratory animal science.

How should sponsors select appropriate animal models for device testing?

Select models that best simulate clinical settings and address study objectives. Consider anatomical and physiological similarities to humans, established models in literature, and consult experienced laboratory animal veterinarians. Use Q-Submission process for FDA feedback.

What monitoring requirements apply during animal studies for medical devices?

Follow current veterinary standards with pre-specified monitoring plans for adverse events. Include intra-procedural physiologic monitoring, post-procedural recovery assessment, daily in-life observations, and protocols for unexpected morbidity and mortality with timely necropsies.

What documentation must be included in animal study reports for FDA submissions?

Include executive summary, final study report signed by study director, quality assurance statement, individual scientist reports, raw data copies, animal medical records, imaging results, and pathology reports with high-resolution photographs and detailed interpretations.

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What You Need to Do 👇

Recommended Actions

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

• 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

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Relevant Guidances 🔗

• Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development
• 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

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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 ID: 56a057aa22a52d49f2acd3fc3b228e35