Compassionate use — formally called Expanded Access by the FDA — allows individual patients with serious or life-threatening conditions to receive investigational devices that have not yet been approved or cleared. For BCI devices still in clinical development, compassionate use represents a potential pathway for patients who cannot wait for the completion of clinical trials and commercial approval.

FDA Framework

The FDA provides several expanded access mechanisms:

  • Individual patient access: For a single patient with a serious condition; requires physician request, IRB approval, and FDA authorization
  • Treatment use: For broader patient access when sufficient evidence exists that the device may be effective and the risk is acceptable
  • Emergency use: For life-threatening situations where there is no time for standard expanded access procedures; FDA notification within 5 days

Criteria

For a BCI device to be available under compassionate use:

  1. The patient has a serious or life-threatening condition
  2. No comparable approved device is available
  3. The potential benefit justifies the potential risks
  4. Use will not interfere with ongoing clinical trials
  5. The device sponsor is willing to provide the device

BCI Implications

Compassionate use is particularly relevant for BCI because the target patient populations — people with ALS, locked-in syndrome, and severe paralysis — face progressive, life-limiting conditions. A patient with rapidly advancing ALS may lose the ability to communicate entirely before a BCI device completes its clinical trial program. Compassionate use provides a legal and ethical framework for early access in such cases.

Practical Challenges

Compassionate use of implanted BCIs faces practical barriers: the neurosurgical procedure requires specialized surgical teams, the BCI system requires technical support for setup and calibration, and the device may require ongoing maintenance that the sponsor must provide outside their clinical trial infrastructure. These logistical requirements limit the practicality of widespread compassionate use for complex implanted devices.