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 […]
Our first special edition #mHealth chat, about FDA regulations and mobile medical apps, was a success thanks to our guest M. Jason Brooke, J.D., FDA regulatory attorney from Washington DC, and many other great participants.
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 […]
Please join us for the next #mHealth chat on Twitter on Wednesday June 6th at 9pm EST/8pm CST using the hashtag #mHealth.
Mobile health and the mHealth app market continues to see substantial growth, and is expected to continue expanding as business models and significant value offerings continue to evolve in tandem with the fast paced world of mobile technologies.
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.
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.
Today, the FDA finally released a detailed draft guidance of how it intends to regulate this rapidly exploding sector of mobile medical devices and software.