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 - Final Guidance

Adele Hughes supports the development of BCI devices but argues that the FDA should implement specific safety and ethical requirements. The commenter advocates for "fail-safes" to distinguish between fleeting thoughts and firm intent, as well as strict limitations on data recording and commercial use of neural data.