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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.

  1. Establish a process to complete the FDA Animal Products Database form for each device containing animal-derived materials
  2. Create a documentation system to track all required information for each animal-derived component
  3. Implement a verification process to ensure all required fields are completed accurately
  4. Maintain records of country of origin and species information for all animal-derived materials
  5. Document all processing steps and sterilization methods used
  6. Create a system to track and update information when changes occur in the supply chain or manufacturing process
  7. 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

  • 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

  • Documentation Requirements for Medical Devices Containing Animal-Derived Materials
  • HTML / PDF
  • Issue date: 1998-11-06
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices
  • ReguVirta summary file ID: 67380bdc6d76a6f181aa8df86ca52fb5
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