Documentation Requirements for Medical Devices Containing Animal-Derived Materials
This guidance provides a standardized form for collecting and documenting information about medical devices containing animal-derived products. It aims to ensure proper tracking and documentation of animal-derived materials used in medical devices.
Recommended Actions
- Establish a process to complete the FDA Animal Products Database form for each device containing animal-derived materials
- Create a documentation system to track all required information for each animal-derived component
- Implement a verification process to ensure all required fields are completed accurately
- Maintain records of country of origin and species information for all animal-derived materials
- Document all processing steps and sterilization methods used
- Create a system to track and update information when changes occur in the supply chain or manufacturing process
- Train relevant personnel on proper completion of the form and importance of accurate documentation
Key Considerations
Labelling
- Device identification information must include:
- Manufacturer name
- Submission number
- Generic Device Name
- Model Identifier or trade name
- Implantation or Tissue contact Duration
Biocompatibility
- Material and animal product information must be documented for each animal-derived component including:
- Type of tissue, cell, or biomolecule
- Species of origin
- Country of origin
- Starting form (purified, recombinant, synthetic)
- Whether the material is bioresorbable
Safety
- Processing information must be documented including:
- Sterilization method used
- Forming and processing methods (e.g., cell/tissue culture, cross-linking, viral inactivation)
- Packaging type
Other considerations
- Organ system and tissue contact information must be specified
- Duration of contact must be indicated (less than 24 hours, 24 hours to 30 days, greater than 30 days)
Relevant Guidances
- Medical Devices Containing Animal-Derived Materials - Safety and Risk Management Requirements
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
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
Original guidance
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