Tag: FDA mHealth

Congress leaves FDA to complete job on mobile health apps regulation

By M. Jason Brooke, JD You might have heard that Congress recently passed legislation that promotes FDA regulation of mobile devices. It’s actually a bit more complicated than that. Congress was instead considering a bill that would muddy the regulatory waters for mobile app developers and distributors as well as smartphone and tablet manufacturers. Here’s what […]

Let’s talk medical apps and the FDA: #mHealth Chat Special Edition Tonight

How should mobile medical apps be regulated by the FDA? Last year the FDA released a proposed set of guidelines for the regulation of certain mobile health apps that control a regulated medical device, or manipulate patient data from a medical device. This has been a source of some controversy and anxiety for many medical app developers. Some argue […]

FDA Regulation of mHealth, Part 1: FDA basics

As many of our readers know, the role of the FDA is evolving with respect to mobile medical software and devices. There is no question that the FDA has jurisdiction to regulate medical software, not to mention a responsibility. In this article, we will examine the basics of FDA regulation of medical devices.