Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails: Guidance for Industry and Food and Drug Administration Staff

Issue Date: March 7, 2016
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), HUD/HDE, General & Plastic Surgery , Good Clinical Practice (GCP), Labeling
Status: Final

Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails: Guidance for Industry and Food and Drug Administration Staff

A variety of diseases can affect the appearance of nails, including fungal infection. This guidance is intended to provide recommendations regarding clinical trial design for medical devices intended either (1) to provide improvement in the appearance of nails affected by onychomycosis, that is, to affect the structure/function of the nails or (2) to treat onychomycosis (fungal nail infection). All marketed devices to date have been 510(k)-cleared for visual improvement, with Indication for Use statements such as “temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans).” Some elements of this guidance will be primarily applicable to non-ablative energy-based devices, although the basic principles may be broadly applicable to all devices.

Download the Guidance Document