FDA Making Plans to Oversee Mobile Medical Apps

In a day and age when smart phones have become so omnipresent that they might as well be extensions of our hands, the FDA is making plans to oversee some of the mobile medical apps that have hit the market.

The agency announced that they plan to oversee apps that:

• Are used as an accessory to an FDA-regulated medical device (such as apps that allow healthcare professionals to view medical images and use them to make a diagnosis)
• Transform a medical platform into a regulated medical device (for example, an app that turns a smart phone into an ECG machine to detect abnormal heart rhythms)

The FDA is hoping to receive as much feedback from consumers, advocacy groups, healthcare professionals, software creators and distributors as possible before they finalize their proposed guidelines. To submit feedback, click here. To learn more, click here.