9 Pages Posted: 4 Jun 2016 Last revised: 27 Jan 2020

Date Written: June 1, 2016

Abstract

In this paper, we highlight one of the key consequences of a product being legally categorized as a medical device by the FDA: that it must clinically prove its medical effectiveness in addition to the risks associated with its use. This places a significant additional burden on producers; one that is not necessarily appropriate when a product is destined for general consumers rather than patients, particularly, when no substantial risks are proven to result from its use. Second, we address the body of scholarship that, rather than asserting the existence of a general regulatory gap when it comes to tDCS devices, argues that there are gaps within general products and medical device regulations specifically. We counter such contentions on two fronts. We note that the lack of a proof of effectiveness requirement under general products regulations is not a gap because, as asserted in the previous section, its absence is not inherently improper for products marketed to ordinary consumers as opposed to patients. For the same reason, the alleged inapplicability of medical device regulations to these tDCS devices is similarly not a regulatory gap. We next illustrate that medical device regulations are not necessarily inapplicable to tDCS devices destined for the general market. Instead, given the broad discretion the FDA has in categorizing something as a medical device, the application of these rules is likely simply a matter of government enforcement. Overall, we call for further discretion and more comprehensive legal analysis from those who argue that additional federal regulation is needed for tDCS devices.