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Non-Clinical Testing and Labeling Requirements for Extracranial Intravascular Stents and Delivery Systems

This guidance addresses self-expanding and balloon expandable extracranial intravascular stents and their associated delivery systems used in coronary or peripheral arteries and saphenous vein grafts. It excludes intracranial stents, non-vascular stents, and provides limited guidance for covered, drug-eluting and biodegradable stents.

  1. Develop comprehensive test plan covering all required non-clinical testing categories
  2. Establish test protocols with clear acceptance criteria before conducting tests
  3. Perform material characterization and biocompatibility testing early in development
  4. Conduct accelerated durability testing to support IDE application (1-year equivalent) and complete 10-year equivalent testing for PMA
  5. Prepare detailed test reports including protocols, results, and data analysis
  6. Document MRI safety testing and develop appropriate labeling
  7. Develop comprehensive labeling including all required sections
  8. Consider additional testing requirements if targeting in-stent restenosis or bifurcation lesions
  9. Establish shelf life testing protocol and initiate real-time aging studies
  10. Prepare test summary checklist documenting all completed testing

Key Considerations

Non-clinical testing

  • Material characterization (composition, shape memory properties, corrosion resistance)
  • Dimensional verification and functional attributes (surface area, foreshortening, recoil, integrity)
  • Radial strength and stiffness testing
  • Stress/strain and fatigue analysis
  • Accelerated durability testing
  • Particulate evaluation
  • Crush and kink resistance (peripheral stents only)

Labeling

  • Device description including dimensions and specifications
  • Indications for use
  • Contraindications, warnings and precautions
  • MRI safety information
  • Clinical studies overview
  • Adverse events reporting
  • Directions for use
  • Patient materials

Biocompatibility

  • Cytotoxicity
  • Sensitization
  • Irritation
  • Systemic toxicity
  • Hemocompatibility
  • Pyrogenicity
  • Additional testing based on materials used

Safety

  • MRI safety and compatibility testing
  • Shelf life testing
  • Delivery system safety testing
  • Stent securement testing

Other considerations

  • ISO 10993: Biological Evaluation of Medical Devices
  • ASTM F138: Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
  • ASTM F2004: Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
  • ASTM F2079: Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon expandable Stents
  • ASTM F2081: Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
  • ASTM F2129: Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements
  • ASTM F2394: Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
  • IEC 60601-2-33: Medical electrical equipment – Part 2-33: Particular requirements for MRI equipment

Original guidance

  • Non-Clinical Testing and Labeling Requirements for Extracranial Intravascular Stents and Delivery Systems
  • HTML / PDF
  • Issue date: 2010-04-17
  • Last changed date: 2024-08-09
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 06ad55d856526f6a9bfdcc480ebc9ac2
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