FDA should regulate digital games, and potentially other apps, as medical devices.
Why, pray tell?
One doesn’t have to look very hard to find a growing belief (recognition?) that video games are addicting. CBS has been on the story since at least 2007. In 2014, “60 minutes” suggested that a violent video game could prompt murder. Well, they posed it as a question, but to raise it as they did sounds kind of like asking someone, “have you stopped beating your wife?” And this past April, they did a piece with a former Google employee who suggested that tech companies are designing games, if not apps in general, to draw people into compulsive use. They revisited the topic, with the same interviewee, in June, using the term “brain hacking.” Frontline on PBS did a series on the topic in 2010, looking at concerns about internet addiction as well as arguments that some games may hone desirable skills.
Concern about the effect our entertainment media have on us, especially on our kids, is certainly not new. Remember Tipper Gore, who, among other things, wrote a book about the subject 30 years ago?
The difference comes if our apps and games are not just addictive and self-reinforcing, but if their creators and marketers not only know it but make them that way on purpose.
According to the FDA, a medical device, subject to premarketing and postmarketing regulatory controls by the FDA, is defined in Section 201(h) of the Food, Drug, and Cosmetic Act as (emphasis mine in what follows):
- “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, OR
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
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.