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# Guide on Implanted Brain-Computer Interface Device
- URL: https://www.fdaweb.com/guide-on-implanted-brain-computer-interface-device/
- Published: 2019-02-25T12:00:00.000Z
- Updated: 2026-09-15T01:07:36.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143455

*Federal Register* notice: FDA has made available a draft guidance entitled “Implanted Brain-Computer Interface Devices for Patients with Paralysis or Amputation — Nonclinical Testing and Clinical Considerations.” The document defines implanted brain-computer interface devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities in patients with paralysis or amputation. This draft guidance provides recommendations for nonclinical testing and study design considerations for IDE feasibility and pivotal clinical studies. To view the notice, click here.