AAMI News April 2019

Draft Guidance 'Leapfrogs' FDA into Regulation of Brain—Computer Interfaces

Brain-Computer Interfaces
The FDA believes brain–computer interface devices have the potential to provide greater mobility and independence for wounded veterans and other Americans affected by paralysis or amputation.

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 nervous system to allow limbs or other prosthetics to be controlled by 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encourage the development of this emerging technology, the Food and Drug Administration (FDA) has released “leapfrog” draft guidance, Implanted Brain–Computer Interface (BCI) Devices for Patients with Paralysis or Amputation—Non-clinical Testing and Clinical Considerations, intended to provide the FDA’s “initial thoughts about regulatory considerations.”

“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 outgoing 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The draft guidance is intended to help device developers design clinical studies of BCI devices as well as conduct nonclinical device testing, utilizing relevant safety standards. 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The FDA is seeking feedback on the draft guidance until April 26 at www.regulations.gov (docket FDA-2014-N-1130-0004).