Anna Wexler writes about her recent paper in Slate.
Last month, the FDA held a public workshop on this topic. (I spoke on one of the panels, though I have no financial interests in these products.) Based on the discussion paper released ahead of the workshop, it seems that the agency intends to regulate these devices—it just hasn’t quite figured out how to do so. But although the FDA may have the expertise to regulate these devices, the idiosyncrasies of medical device law—namely, the complications regarding “intended use” claims—may not make this the best option, especially given the recent entrance to the market of devices that make no claims at all and instead bill themselves as “direct current sources.” The situation may require a novel solution—such as collaboration between the FDA and CPSC or the involvement of a third party, such as the National Academy of Medicine—to ensure the construction of a coherent framework that best encompasses devices on the market now and anticipates the complex issues that may arise in the future.
Source: How Should We Regulate Those Brain-Zapping Gadgets That Promise to Boost Your Memory?