# 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 - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/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/012c0761-c8dd-44b6-a0ad-6e11698baf50

> FDA guidance document: 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. Issue date: May 20, 2021. Get complete insights and analysis.

---

## Details

- Title: 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
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2021-05-20
- Last Changed: 2021-05-19
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2014-N-1130">FDA-2014-N-1130</a>

## Related Documents

- [Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/policy-clarification-and-premarket-notification-510k-submissions-for-ultrasonic-diathermy-devices-guidance-for-industry-and-food-and-drug-administration-staff/ab06388f-a3b0-4c35-a1b7-ab5befb36526)
- [Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/peripheral-vascular-atherectomy-devices-premarket-notification-510k-submissions-guidance-for-industry-and-food-and-drug-administration-staff/2b1144d8-b7d4-40e7-b482-d9d591a966fd)
- [Display Devices for Diagnostic Radiology:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/display-devices-for-diagnostic-radiology-guidance-for-industry-and-food-and-drug-administration-staff/b1d79a2b-9d9a-4a18-b182-4f6f13e9b51b)