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Vocal Fold Medialization Devices - Testing and Documentation Requirements

This guidance covers vocal fold medialization devices (procode MIX and KHJ) including injectable materials and materials used in Type I thyroplasty procedures to medialize the vocal fold through external cervical skin incision. The document excludes certain polymers and elastomers regulated under 21 CFR 874.3620.

  1. Conduct comprehensive risk analysis
  2. Perform required biocompatibility testing
  3. Complete material characterization and performance testing
  4. Conduct animal studies for new materials
  5. Validate sterilization processes if applicable
  6. Prepare detailed labeling with surgical instructions
  7. Consider if clinical studies are needed based on device novelty
  8. Document all testing results in design history file
  9. Prepare 510(k) submission with all required elements
  10. Consult with FDA’s ENT Devices Branch for any questions

Key Considerations

Clinical testing

  • Clinical studies may be required for:
    • Materials/designs dissimilar from previously cleared devices
    • New technologies
    • Novel indications for use
  • Studies must comply with IDE regulations as significant risk devices

Non-clinical testing

  • Long-term animal studies (1 year) recommended for new materials
  • Animal studies needed to demonstrate:
    • Lack of granulomatous inflammation
    • No material migration
    • Include appropriate controls

Labeling

  • Clear surgical technique instructions
  • Revision surgery guidance
  • Special considerations for injectable materials
  • Airway protection/compromise information
  • Postoperative complications
  • Patient instructions
  • Cautions, precautions and warnings

Biocompatibility

  • Evaluate according to ISO 10993 Parts 1, 5 and 10
  • Long-term implantation studies needed for new materials
  • Assess tissue/bone contact compatibility
  • Document results in design history file

Safety

  • Evaluate risks of:
    • Airway compromise
    • Device extrusion/migration
    • Infection
    • Adverse tissue reactions
    • Device breakage
    • Poor voice quality

Other considerations

  • ISO 10993-1: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
  • ISO 10993-5: Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity
  • ISO 10993-10: Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization

Original guidance

  • Vocal Fold Medialization Devices - Testing and Documentation Requirements
  • HTML / PDF
  • Issue date: 2004-02-12
  • Last changed date: 2020-03-24
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 5ffa51a6cf8227cb7692a73888cabea2
This post is licensed under CC BY 4.0 by the author.