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. What is not clear yet is which regulatory pathway NeuroRacer will trundle down. Many medical devices submitted for the agency’s approval rely on the “piggyback” mechanism, known as 510(k), whereby a device can skip the “clinical trial” pre-market approval requirement if the FDA is convinced that the device is “substantially similar” to a previously approved device.
What will happen, though, if NeuroRacer is simply too novel for 510(k)? CLB Fellow Patti Zettler notes that the FDA has a de novo classification pathway for low-risk devices (which NeuroRacer surely must be, notwithstanding the tut-tutting of certain embattled politicians), a pathway that would ease the game’s journey through the approval process. In the alternative, Prof. Gazzaley might just choose to play this by the book and pony up sufficient safety and efficacy data to win full-fledge pre-market approval. It is possible that the FDA’s new “Unmet Medical Need” guidance for devices might be implicated here, which would provide yet another tactic for expediting approval. But in order to take advantage of it, NeuroRacer would have to “treat or diagnose a life-threatening or irreversibly debilitating condition.” Age-related cognitive decline is irreversibly debilitating in some sense, but the agency’s definition of that term in the published guidance is rather stringent.
Even if NeuroRacer must slog through the full pre-market approval workup, my intuition is that the game stands a decent chance of winning approval, at least eventually. Moreover, I hope it succeeds, for several reasons. First, it would be wonderful to expand our repertoire of brain-therapeutic neurotechnologies, especially in a direction that moves us away from pharmacological interventions. Not to put too fine a point on it, but even when pills are effective for what ails your brain, they still tend to be pretty awful.
Second, productively involving the FDA in this industry would amount to a significant first step in shining some regulatory sunlight on a market that could use some disinfecting. Not at all to imply that any of the brain-training games out there are unsafe in the sense of being bad for your health, but there is no shortage of unsubstantiated puffery when it comes to the positive effects of some such games, which certainly harms consumers in a different sense. Bringing the FDA into the picture would set a positive precedent, inducing other companies to put up or shut up.
Finally, it would simply be gratifying to see a video game win FDA approval. The medium has been evolving at a dizzying pace in the past few decades, and at this point, people who think of video games fundamentally as children’s toys tend to be singularly incurious types whose understanding of the world is permanently stalled in the 1980s — which is to say, quite a lot of people. Success at the FDA would jar a few more people out of their antediluvian understanding of what video games are, and would further consolidate the medium’s respectability.
Watch this space for further developments. We hope to learn a bit more about the strategic details of NeuroRacer’s bid for approval soon.
Roland Nadler is a second year student in the Stanford Law School JD program and is a student fellow at the Center for Law and the Biosciences.