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 | Guideline Explorer

Description

This guidance document provides recommendations for nonclinical testing and study design considerations for Investigational Device Exemptions (IDEs) feasibility and pivotal clinical studies for implanted Brain-Computer Interface (BCI) devices for patients with paralysis or amputation. The field of implanted BCI devices is progressing rapidly from fundamental neuroscience discoveries to translational applications and market access. Implanted BCI devices have the potential to bring benefit to people with severe disabilities by increasing their ability to interact with their environment, and consequently, providing new independence in daily life. For the purposes of this guidance document, implanted BCI devices are neuroprostheses that interface with the central or peripheral nervous system to restore lost motor and/or sensory capabilities in patients with paralysis or amputation.

Scope & Applicability

Product Classes

3

Implanted Brain-Computer Interface (BCI) Devices

Implanted BCI devices are neuroprostheses that interface with the central or peripheral nervous system.; Guidance for non-clinical testing and clinical considerations for BCI devices.

Implanted BCI Devices

Scope of the guidance document focusing on devices interfacing with the nervous system

Implanted BCI Device

Subject of the guidance document regarding non-clinical and clinical testing.; Subject of the guidance regarding non-clinical testing and clinical considerations.; Brain-Computer Interface device system including electrodes, leads, and casing.; long-term clinical durability and reliability are important factors to long-term efficacy

Stakeholders

4

Regulatory Context

Attributes

10

Enhanced Documentation Level

Level of documentation required based on risk; higher documentation threshold for software functions; Risk-based documentation category requiring more detail; Outcome for software functions where failure presents a probable risk of death or serious injury; Outcome for devices where software failure presents a probable risk of death or serious injury.

Compliance voltage

Specification for current source output modes

Duty Cycle

Calculated as pulses per burst multiplied by bursts per second

Leakage Current

Current that is not functional

Net DC Current

Current due to charge imbalance or incomplete charge recovery

Maximum Charge Density

Calculated using the conductive surface area of the smallest electrode

Maximum Output Current

Output characteristic to be reported at 500 ohms

Maximum Output Voltage

Output characteristic to be reported at specific impedances

Primary effectiveness endpoint

how the primary effectiveness endpoint was validated

Primary safety endpoint

characterization of all adverse events

Identified Hazards

Hazards

10

Adverse tissue reaction

Risk management information should identify hazardous situations such as adverse tissue reaction.

Electrode corrosion

Risk resulting from charge imbalance

Autonomic dysreflexia

history of poorly controlled autonomic dysreflexia

Seizure

exclusion criteria for clinical study

Insulation degradation

Failure mode for device components.

Corrosion

Failure mechanism to detect during explanted device evaluation.

Tissue heating

Potential risk from inductive coupling in RF transmitters.

Tissue damage

Risk caused by inadvertent overuse or high irradiance leading to thermal injury.; Misuse of the device might lead to injury

Particulate Matter Hazards

Release of particulate matter in contact with body fluids is hazardous.