FDA will not regulate 'low-risk' healthcare technologies, apps

Users of Fitbits and Weight Watchers can breathe a sigh of relief after the FDA announced its guidance stating that it would not be regulating low-risk products like mobile health and fitness apps.

The guidance comes into place as our technologies are evolving constantly, and mobile and apps are one of the most to advance thanks to new technology. The FDA not regulating these low-risk products gives them more room to grow and use innovation to get people more active and involved in their own health.

“I’m glad to see that the FDA recognizes this and has no current plans to put unnecessary government red tape between people hoping to use a Fitbit to help them get moving or a Weight Watchers application to monitor their diet,” stated Senate health committee Chairman Lamar Alexander.

The FDA will continue to regulate products that are invasive or implanted but this step out of the realm of wearable technology opens the doors for developers to let their imagination run wild.