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# FDA Guidance on Device Trials for Nail Fungus Treatment
- URL: https://www.fdaweb.com/fda-guidance-on-device-trials-for-nail-fungus-treatment/
- Published: 2016-03-04T12:00:00.000Z
- Updated: 2026-09-15T02:40:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134972

> FDA has posted a [guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM431312.pdf?ref=fdaweb.com) on “Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails” that provides recommendations on clinical trial designs for devices intended either (**1**) to provide improvement in the appearance of nails affected by onychomycosis; or (**2**) to treat onychomycosis. Some guidance elements are primarily applicable to non-ablative energy-based devices, the agency says, although the basic principles may be broadly applicable to all devices.  
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> An indication for treating onychomycosis (an infectious disease) requires proof of stable elimination of the fungal organism, which is a medical endpoint, the guidance says. “This outcome is distinct from outcomes limited to ‘temporary increase in clear nail’ in nails which are fungally-infected, which is considered an aesthetic endpoint, and does not necessarily signify successful eradication of fungal infection, but rather an effect on the structure/function of the nails,” it says. “The agency recognizes that this endpoint may have functional benefits as well, which may be of some value to the patient if the improvement in appearance or function is clinically significant and if the benefits outweigh potential risks of the treatment. Nonetheless, claims related to appearance remain distinct from claims of eliminating fungal infection.”