Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: 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), Premarket
Published
October 1, 2013
Last updated
February 28, 2020
Description
This document provides guidance for conducting early feasibility medical device clinical studies, including first in human studies, for FDA staff and industry.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)