Digital Health and Regulatory Experimentation at the FDA

Abstract

For well over a decade the U.S. Food and Drug Administration (FDA) has been told that its framework for regulating traditional medical devices is not modern or flexible enough to address increasingly novel digital health technologies. Very recently, however, the FDA introduced a series of digital health initiatives that represent important experiments in medical product regulation, departing from longstanding precedents applied to therapeutic products like drugs and devices. The FDA will experiment with shifting its scrutiny from the pre-market to the post-market phase, shifting the locus of regulation from products to firms, and shifting from centralized government review to decentralized non-government review. This Article evaluates these new regulatory approaches, explains how they depart from previous approaches, and discusses why these experiments themselves require evaluation moving forward.

Keywords: U.S. Food and Drug Administration, FDA, medical devices – regulation, digital health technologies, digital health initiatives