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.
What You Need to Know? 👇
What is the FDA Animal Products Database and when should it be used?
The FDA Animal Products Database is a data collection system for medical devices containing animal-derived materials. Manufacturers must complete separate forms for device identification and each animal product/component when submitting devices that contain materials from animal sources.
Which organ systems and tissue contacts must be documented for animal-derived medical devices?
The form requires identification of the primary organ system (cardiovascular, dental, gastrointestinal, etc.) and specific tissue contact (blood, bone, heart, etc.) where the device will be used. This helps FDA assess biocompatibility and safety risks.
What animal species information is required for FDA submissions?
Manufacturers must specify the exact animal species (bovine, porcine, ovine, etc.), country of origin, and whether the material is bioresorbable. This information is critical for assessing potential disease transmission risks and material compatibility.
What types of animal-derived materials are covered in the database?
The database covers three main categories: tissues (bone, cartilage, heart valves), cells (adipocytes, fibroblasts, osteoblasts), and biomolecules (collagen, albumin, hyaluronic acid). Each category requires specific documentation of source and processing methods.
What sterilization and packaging information must be provided?
The form requires documentation of sterilization methods (gamma radiation, ethylene oxide, steam, etc.) and packaging types (blister packs, inert gas packs, etc.). This ensures proper sterility validation and shelf-life determination for animal-derived components.
What processing information is required for animal-derived device components?
Manufacturers must document all fabrication processes including cross-linking, enzyme treatment, chemical fixation, viral inactivation, and demineralization. This processing history is essential for understanding material properties and potential immunogenic responses.
What You Need to Do 👇
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