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
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Good Clinical Practice (GCP), Investigational Device Exemption (IDE), Labeling, Premarket
Published
March 7, 2016
Last updated
February 9, 2019
Description
This document provides guidance on clinical trial design for medical devices treating or improving the appearance of fungally-infected nails.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)