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.
Well done! Anita Jwa’s study of the DIY tDCS community is published. I would think this very useful to policy makers. I was only surprised by a few of her findings. Links below to full paper.
This study is the first empirical attempt to investigate the DIY tDCS user community. A questionnaire survey of DIY users, interviews with some active power users, and a content analysis of web postings on tDCS showed distinctive demographic characteristics of the DIY users, ambiguities and mistaken assumptions around the current state and future prospects of the DIY use of tDCS, mixed use of tDCS for both treatment and cognitive enhancement, the existence of an active self-regulating system in the community, and users’ demands for official guidelines and their concerns about government regulations on tDCS.