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.
Recommended Actions
- Conduct comprehensive risk analysis
- Perform required biocompatibility testing
- Complete material characterization and performance testing
- Conduct animal studies for new materials
- Validate sterilization processes if applicable
- Prepare detailed labeling with surgical instructions
- Consider if clinical studies are needed based on device novelty
- Document all testing results in design history file
- Prepare 510(k) submission with all required elements
- 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
- Material characterization required:
- Chemical stability
- Mechanical properties for solid materials
- Physical/chemical analysis for injectables
- Sterilization validation and packaging information needed for sterile devices
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 Controls for Medical Device Manufacturers
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms
- 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
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