Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Investigational Device Exemption (IDE), Premarket
Published
May 20, 2021
Last updated
May 19, 2021
Description
This document provides guidance for non-clinical testing and clinical considerations of implanted Brain-Computer Interface (BCI) devices for patients with paralysis or amputation.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)