The FDA and the Future of the Brain-Computer Interface: Adapting FDA Device Law to the Challenges of Human-Machine Enhancement

Eric D. Chan, Stanford Law School

Abstract

The neuroelectronic interface is an emerging technology that uses electric signals to communicate directly with the human brain. It promises to make possible a new generation of user-worn prosthetic devices that can be controlled at the speed of thought, functioning as actual extensions of the human body. Prototypes already exist, though they are still in development – artificial retinas, which can provide replacement sight for the blind; sophisticated prosthetic limbs. Though current applications are geared towards replacing lost natural function, there is no reason that these brain-computer interface devices cannot also be used to enhance the capabilities of a healthy human body. Neuroelectronic devices may not only allow humans to run faster, jump higher, and see farther, but they might potentially impart new forms of sensory perception and control over the world that were previously unimaginable.

This paper explores the new safety risks and burgeoning legal and ethical implications of neuroelectronic enhancement devices under U.S. Food & Drug Administration law. It argues that the Premarket Approval regime administered by FDA’s Center for Devices and Radiological Health is deficient in two respects when it comes to these futuristic devices. First, by focusing on device approval as the sole regulatory event, FDA fails to effectively ensure the safety and effectiveness in the long term–over the life of a user. Second, FDA’s “procedural” regulatory regime does not consider the moral, ethical and social considerations–“substantive” concerns–that enhancement devices will implicate. Only regulation that accounts for these issues can raise public awareness and prevent the inevitable public backlash and moratorium on neuroelectronic development when something goes wrong.

This paper thus proposes two main modifications to existing FDA device law. FDA should create a new “Class IV” designation for neuroelectronic devices, implementing along the way a two-tiered approval process to better assess long-term risks of safety and effectiveness. In order to consider the broader questions of enhancement itself, a“Class IV-E” sub-designation should be established to review Class IV devices that have “significant potential” to enhance human abilities.