Draft Guidance ‘Leapfrogs’ FDA into Regulation of Brain–Computer Interfaces


Posted February 26, 2019

For people affected by paralysis or an amputation, devices that can bridge the gap between the brain and computers—called brain–computer interfaces (BCIs)—hold great promise. These devices can be implanted into the brain or parts of the nervous system to allow limbs or other prosthetics to be controlled with the patient’s thoughts.

To help encourage the development of this emerging technology, the Food and Drug Administration (FDA) has released “leapfrog” draft guidance, Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations, which provides technical direction to manufacturers developing this technology and recommendations for Q-Submissions and Investigational Device Exemptions for implanted BCI devices.

“The idea that a prosthetic could interact with the brain has been the topic of much imagination, but now we’re actually on the verge of realizing this opportunity. The FDA has an important role to play by laying out a path for developers on how to seize this prospect and advance the development of new devices,” said FDA Commissioner Scott Gottlieb in a statement. “Our work on BCI devices also reflects our deep commitment to help the men and women who bravely served our country … we believe that BCI technology has the potential to improve wounded veterans’ lives and those of other Americans in regaining mobility and thus improving their quality of life.”

The draft guidance is intended to help device developers design clinical studies of BCI devices as well as conduct non-clinical device testing, utilizing relevant safety standards. According to the draft guidance, non-clinical device testing can be used to demonstrate that potential risks have been mitigated prior to beginning a clinical study. The guidance document also describes methods to evaluate biocompatibility with human tissue (e.g., blood, cerebrospinal fluid), maintain compliance with electrical and electromagnetic safety standards, and establish compatibility with MRI machines and wireless signals.

The draft guidance is the product of a 2014 FDA public workshop that discussed the scientific and clinical considerations associated with the development of BCI devices. As a leapfrog guidance document, it is intended to bridge the present state of health technology with the future by providing the FDA’s “initial thoughts about regulatory considerations.” However, as the FDA takes into account new information, technological development, and public input, its recommendations are likely to evolve, Gottlieb said.

The FDA is seeking feedback on the draft guidance at www.regulations.gov (docket FDA-2014-N-1130-0004) until April 26.