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Clinical Trial Design and Regulatory Considerations for Nail Appearance and Onychomycosis Treatment Devices

This guidance provides recommendations for clinical trial design and regulatory considerations for medical devices intended to either provide improvement in the appearance of nails affected by onychomycosis (aesthetic endpoint) or to treat onychomycosis (medical endpoint - fungal nail infection). It applies to devices seeking clearance through 510(k), de novo, or PMA pathways.

  1. Determine if seeking aesthetic improvement or treatment indication as this impacts study design
  2. For clinical studies:
    • Develop detailed protocol with pre-specified endpoints
    • Include appropriate controls and blinding
    • Plan for adequate follow-up duration
    • Establish clear inclusion/exclusion criteria
    • Document all adverse events
  3. For labeling:
    • Clearly distinguish between aesthetic vs treatment claims
    • Include all required warnings and limitations
    • Provide representative photos and data
    • Detail any required adjunctive therapies
  4. For submissions:
    • Consider pre-submission meeting with FDA
    • Include complete statistical analysis plan
    • Provide detailed device specifications if energy-based
    • Document all safety measures
  5. For post-market:
    • Monitor and report adverse events
    • Ensure labeling compliance
    • Maintain records of device performance

Key Considerations

Clinical testing

  • Must confirm fungal infection in enrolled subjects through stains and cultures
  • Recommended follow-up periods: 6 months for fingernails, 12 months for toenails
  • Need to demonstrate progressive improvement at multiple timepoints
  • Should exclude vulnerable populations (diabetics, immunocompromised, etc.)
  • Need clear responder definitions based on nail measurements
  • Should assess both visual improvement and mycological cure for treatment indication

Labelling

  • Must clearly distinguish between aesthetic improvement vs treatment claims
  • Need warning for use in vulnerable populations
  • Must include representative before/after photos
  • Must specify any adjunctive therapies required
  • Must include response rates and adverse events data
  • Must specify fungal species assessed

Safety

  • Must monitor and report all adverse events
  • Special attention to burns, infections, nerve damage risks
  • Additional safety considerations for darker skin types with light-based devices

Other considerations

  • 21 CFR 3.2(e): Combination Products

Original guidance

  • Clinical Trial Design and Regulatory Considerations for Nail Appearance and Onychomycosis Treatment Devices
  • HTML / PDF
  • Issue date: 2016-03-07
  • Last changed date: 2019-02-09
  • Status: FINAL
  • Official FDA topics: Medical Devices, Good Clinical Practice (GCP), General & Plastic Surgery, Premarket Approval (PMA), 510(k), Premarket, Labeling, HUD/HDE, Investigational Device Exemption (IDE)
  • ReguVirta summary file ID: e1f3d710e531c9284b4471c62a6eed4d
This post is licensed under CC BY 4.0 by the author.