Organ Preservation Solutions for Transplantation - Testing and Development Requirements

Recommended Actions

1. Develop comprehensive device description including chemical composition and manufacturing process
2. Conduct bench testing for stability and particulate analysis
3. Perform animal studies with appropriate models
4. Design and implement multi-center clinical trial with minimum three sites
5. Establish appropriate primary and secondary endpoints based on organ type
6. Develop statistical analysis plan
7. Ensure packaging materials meet biocompatibility requirements
8. Conduct sterility testing
9. Document preservation times for all organs
10. Consider including at least one US site in clinical studies
11. Prepare comprehensive documentation of all prior investigations and published literature

Key Considerations

Clinical testing

• Multi-center, prospective, randomized, controlled trial recommended
• Minimum of three investigational sites
• Primary endpoint: 7-day patient survival (heart, lung, liver) or 7-day graft survival (kidney)
• 30-day follow-up strongly recommended
• Secondary endpoints specific to organ function required

Non-clinical testing

• Bench testing for product stability under proper and worst-case conditions
• Analysis of chemical constituents and degradation products
• Particulate measurement meeting USP specifications
• Animal testing required for safety demonstration
• Large animal model recommended for confirmatory studies

Biocompatibility

• Packaging material must be appropriate for blood/tissue contact
• Testing according to ISO 10993-1 required for packaging materials
• Alternative: identification of legally marketed product using same materials

Safety

• Sterility testing required (endotoxin and bacteria)
• Chemical components should be USP grade
• Solutions must meet USP specifications for large volume parenteral solutions

Other considerations

• Complete chemical composition listing required
• Manufacturing process description needed
• Stability testing data required
• Statistical plan must be provided
• Foreign clinical data acceptable but at least one US site recommended

  Relevant Guidances

• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Biological Evaluation of Medical Devices Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
• Design Considerations for Medical Device Pivotal Clinical Studies

Related references and norms

• ISO 10993-1: Biological Evaluation of Medical Devices Part-1: Evaluation and Testing
• USP: United States Pharmacopoeia specifications for large volume parenteral solutions

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Original guidance

• Organ Preservation Solutions for Transplantation - Testing and Development Requirements
• HTML / PDF
• Issue date: 2001-01-15
• Last changed date: 2020-03-19
• Status: FINAL
• Official FDA topics: Medical Devices, Investigational Device Exemption (IDE), Premarket
• ReguVirta summary file ID: 57e4762621d854a76d060096e3ce2271