FDA Seeks To Regulate Critical Health Apps

[cdmagurus.com]

The US Food and Drug Administration today announced draft guidelines for how it should regulate health-related mobile apps. The agency is seeking input, but currently proposes that it regulate just two specific types of apps. The first category is apps "used as an accessory to medical device already regulated by the FDA," such as a remote medical scan viewer, used by doctors to diagnose patients. The second category is apps that essentially transform the mobile device into a medical device, such as an app that works with a sensor to detect abnormal heart rhythms. The FDA is not proposing to regulate more benign apps, such as those that offer diet and fitness guidance.



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