> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guide on Implanted Brain-Computer Interface Devices
- URL: https://www.fdaweb.com/guide-on-implanted-brain-computer-interface-devices/
- Published: 2019-02-22T12:00:00.000Z
- Updated: 2026-09-15T01:07:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143443

FDA has released a [draft guidance](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM631786.pdf?ref=fdaweb.com) entitled “Implanted Brain-Computer Interface (BCI) 1 Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Considerations.” The document provides non-clinical testing and clinical study design recommendations associated with implanted BCI devices. The scope of this document is limited to implanted BCI devices that interface with the nervous system to restore motor or sensory capabilities in patients with paralysis or amputation. The agency strongly encourages manufacturers to engage with CDRH through the submission process to obtain more detailed feedback for BCI devices.