Ioana Ciopraga


"This Note critiques the guidance document released by the Food and Drug Administration (“FDA”) in connection with the medical mobile apps it intends to regulate and the regulations that govern medical mobile apps. Specifically, the main argument of this Note is that, while the document is clearly a step in the right direction, significantly more guidance, focused on the characteristics of this new field, such as the rapid change of mobile technology, and on the transformational impact on healthcare of health IT in general and mHealth in particular, should follow soon. Part I provides an overview of the guidance document, with a focus on the FDA’s attempt to find the right balance between regulating apps that could potentially be harmful, and trying to promote innovation. Part II reviews the FDA regulations for medical devices in general, which the FDA used in its guidance document for medical mobile apps. Part III discusses ambiguities in the guidance document, the difficulties mobile app developers may encounter in trying to comply with it, the huge gap between the ability of conventional medical device manufacturers and that of medical mobile app manufacturers to go through the premarket approval process, and how the way the FDA intends to regulate medical mobile apps may ultimately impact innovation in the field. Part IV looks at potential solutions to improve the current regulations and strike the balance between ensuring safety and supporting innovation, and argues for a change in the way the FDA approaches regulation of mobile medical apps, which should incorporate a clear reflection of a field that is constantly evolving at a very fast pace, with very different players than the traditional medical device manufacturers, and for which a 40-year old framework is simply outdated."