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# Guidance on Devices to Treat Fungally-Infected Nails
- URL: https://www.fdaweb.com/guidance-on-devices-to-treat-fungally-infected-nails/
- Published: 2016-03-07T12:00:00.000Z
- Updated: 2026-09-15T02:41:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134987

*Federal Register* Notice: FDA is making available a guidance entitled *Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails*. It is intended to provide recommendations on clinical trial design for medical devices intended either to provide improvement in the appearance of nails affected by onychomycosis or to treat onychomycosis (fungal nail infection). To download this guidance, click [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM431312?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-03-07/pdf/2016-04946.pdf?ref=fdaweb.com)