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.
What You Need to Know? 👇
What are the key requirements for documenting animal tissue sources in medical devices?
FDA recommends documenting animal species, age at slaughter, specific tissues used, country of origin, herd health monitoring methods, transportation conditions, USDA abattoir status, testing protocols, and release criteria for all animal-derived materials used in device manufacturing.
Which ISO standards should manufacturers follow for animal-derived medical devices?
Manufacturers should follow ISO 22442 series: Part 1 (risk management application), Part 2 (sourcing and handling controls), and Part 3 (virus and TSE agent validation). These standards provide comprehensive guidance for managing risks associated with animal tissues in medical devices.
How should viral inactivation studies be conducted for animal tissue-derived devices?
Viral inactivation studies should demonstrate at least 6-log reduction in virus concentration compared to unprocessed source material. Studies must use appropriate model viruses reflecting actual contaminants and evaluate scaled-down versions of production and sterilization processes under commercial manufacturing conditions.
What special considerations apply to ruminant-derived materials regarding TSE risks?
For ruminant materials, manufacturers must document BSE risk status per OIE classification, long-term herd health records, animal feed composition history, slaughter methods preventing cross-contamination, and ante/postmortem inspection details including any PrPTSE testing performed.
Are there exemptions from this guidance for certain animal-derived materials?
Yes, the guidance excludes in vitro diagnostic devices and materials generally recognized as safe based on manufacturing methods, such as tallow derivatives described in ISO 22442-1 Annex C. Crustacean-derived materials have reduced requirements due to lower human pathogen contamination risk.
What sterilization standards are recommended for devices containing animal tissues?
FDA recommends following recognized consensus standards including ISO 11135 (ethylene oxide), ISO 17665-1 (moist heat), ISO 11137-1 (radiation), ISO 14160 (liquid chemical agents), and ISO 14937 (general sterilization requirements) for validating sterilization processes.
What You Need to Do 👇
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