Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Advisory Committees, Clinical - Medical, Good Clinical Practice (GCP), Labeling, Premarket, Safety - Issues, Errors, And Problems
Published
November 7, 2016
Last updated
February 14, 2019
Description
This document provides guidance for industry and FDA staff on clinical considerations for investigational neurological devices targeting disease progression and clinical outcomes.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)