Implanted Brain-Computer Interface Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations (Draft Guidance for Industry)

Policy Details

Policy Details

Last Action
Guidance Issued
Date of Last Action
Feb 25 2019
Date Introduced
Feb 25 2019
Publication Date
Feb 25 2019

SciPol Summary

On February 25, 2019, the Food and Drug Administration (FDA) released draft industry guidelines titled Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation – Non-Clinical Testing and Clinical Considerations. BCI devices can allow amputees to control limb prostheses through consciously directed thought. These guidelines were released to inform manufacturers of the FDA’s current thinking regarding what types of information is expected and required for approval of these devices through both Q-Submissions and Investigational Device Exemptions (IDE). A Q-Submission allows medical device manufacturers to discuss specific aspects of the regulatory process with members of the FDA prior to clinical testing. Whereas, IDEs allow investigational devices to be used in a clinical study to obtain safety and efficacy data.  If a company receives an IDE, the device "leap-frogs" other devices in order to expedite approval for animal and clinical testing. 

Within each draft for a Q-Submission or IDE, the FDA recommends that a detailed description of the device be included (e.g., electrodes, connectors, battery, algorithm). It is also recommended that the device meet various measures of safety prior to clinical testing. This includes markers related to device sterility, biocompatibility, pyrogenicity (i.e., the capacity to prevent the growth of gram-negative bacteria), electromagnetic and magnetic resonance compatibility, and electrical safety.  In addition, the FDA recommends that BCIs have the capacity for wireless communication.  Lastly, the FDA recommends guidelines for both animal and clinical testing of BCIs.

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