Bioethics Blogs

“NeuroRacer” Creator Gazzaley Seeks FDA Blessing for Brain Training Game

Roland Nadler

Three of my favorite topics — cognitive enhancement, administrative law, and video games — have collided in the headlines this weekend, with several games and tech news outlets reporting on a University of California San Francisco professor’s newly announced bid for U.S. Food and Drug Administration recognition that his lab-developed video game, NeuroRacer, is a safe and effective device for the treatment of cognitive decline in the elderly.

NeuroRacer may look like a simple driving sim (you can see some gameplay here), but Adam Gazzaley and his team have fine-tuned the game’s dynamic, self-adjusting difficulty settings to engage the brain in a way that strengthens multitasking skills. Now his task is to convince the FDA that he has the data to prove its beneficial effects are more than virtual reality. The idea of seeking approval from a drug regulatory agency for a video game might strike some readers as a novelty, but when it comes to the FDA’s regulatory jurisdiction, the definition of “medical device” is quite broad and can easily encompass such a technology. Moreover, Gazzaley is not the first to take a game through the agency’s approval process: a company called Brain Plasticity Inc. initiated a similar process back in 2011. (Posit Science, the group behind Brain Plasticity Inc., is mentioned alongside Prof. Gazzaley in this interesting Wired Magazine piece.)

Consistent with what commentators on cognitive enhancement have generally predicted, Prof. Gazzaley and his group will set out to win the FDA’s regulatory clearance to market the game as a treatment for the infirmities of elderly brains rather than as a booster for already-spry ones.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.