Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions: Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Medical Devices
Topics
Clinical - Medical, Investigational Device Exemption (IDE), Premarket
Published
January 13, 2017
Last updated
October 20, 2020
Description
This document provides guidance for sponsors, investigators, and FDA staff on making benefit-risk determinations for medical device investigational exemptions.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)