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 […]
Tag: FDA regulation mHealth
FDA regulation of mHealth, part 2: FDA scope & culture
In this article, we are going to delve a bit into FDA culture, the recent final ruling on “MDDS” devices and try to guess how the FDA will interact with future mHealth devices.
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.
FDA finally issues highly anticipated draft guidance on regulation of mHealth apps
Today, the FDA finally released a detailed draft guidance of how it intends to regulate this rapidly exploding sector of mobile medical devices and software.