Medical Devices Containing Animal-Derived Materials - Safety and Risk Management Requirements
This guidance applies to all medical devices containing or exposed to animal-derived materials (bovine, ovine, porcine, avian), except for in vitro diagnostic devices and materials generally recognized as safe based on their manufacturing method. It addresses risks of human pathogens that could contaminate animal material and be present in medical devices, considering both direct and indirect contact with patients and healthcare providers.
Recommended Actions
- Document complete animal sourcing information including species, age, origin, health status
- Implement and document manufacturing controls for tissue processing
- Validate sterilization processes according to applicable standards
- Conduct viral inactivation studies when viral contamination is a risk
- Implement special controls for TSE/BSE risk materials from ruminant animals
- Maintain detailed records of all tissue sourcing and processing steps
- Establish purchasing controls for animal-derived materials
- Document facility decontamination procedures
- Prepare comprehensive documentation for premarket submissions
- Consider consulting with FDA for specific questions about applicability to your device
Key Considerations
Non-clinical testing
- Viral inactivation/clearance studies required when viral pathogens are a risk
- Model viruses should reflect actual viral contaminants that may be present
- Overall virus reduction factor should demonstrate sufficient safety (typically 6 log reduction)
- Kinetics of viral inactivation studies recommended when possible
Biocompatibility
- Material Safety Data Sheets should be provided when available
- Information on reagents used in tissue processing needed to support biocompatibility assessment
Safety
- Documentation of animal source and handling required
- Control of animal tissue collection (species, age, country of origin, herd status, health monitoring)
- Manufacturing controls for tissue components
- Sterilization validation
- Special considerations for TSE/BSE risk materials
- Quarantine procedures for tissues
- Facility decontamination procedures
Other considerations
- Quality System requirements apply
- Purchasing controls for animal-derived materials
- Record keeping requirements
- USDA/APHIS compliance documentation when applicable
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Immunological Testing for Medical Devices: Evaluation and Assessment of Adverse Effects
- Chemical Analysis in Medical Device Biocompatibility Assessment (Draft)
Related references and norms
- ISO 22442-1: Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management
- ISO 22442-2: Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling
- ISO 22442-3: Medical devices utilizing animal tissues and their derivatives – Part 3: Validation of the elimination and/or inactivation of viruses and TSE agents
- ISO 11135: Sterilization of health-care products – Ethylene oxide
- ISO 17665-1: Sterilization of health care products – Moist heat
- ISO 11137-1: Sterilization of health care products – Radiation
- ISO 11737-1: Sterilization of medical devices – Microbiological methods – Part 1
- ISO 11737-2: Sterilization of medical devices – Microbiological methods – Part 2
- ISO 14160: Sterilization of health care products – Liquid chemical sterilizing agents
- ISO 14937: Sterilization of health care products – General requirements
Original guidance
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