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.
Recommended Actions
- Determine if seeking aesthetic improvement or treatment indication as this impacts study design
- 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
- 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
- For submissions:
- Consider pre-submission meeting with FDA
- Include complete statistical analysis plan
- Provide detailed device specifications if energy-based
- Document all safety measures
- 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
- Statistical analysis plan must be pre-specified
- Blinding recommended whenever possible
- Control groups recommended (contralateral preferred)
- Need to specify dose considerations for different nail sizes/locations
- Cannot combine with oral antifungal medications in studies
Relevant Guidances
- Design Controls for Medical Device Manufacturers
- Benefit-Risk Determinations for Medical Device Premarket Review
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- De Novo Classification Process for Novel Medical Devices Without Predicates
Related references and norms
- 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.