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FDA Releases Guidelines for Mobile Medical Apps

The agency will regulate only apps "that have the potential to harm consumers."


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The mobile development industry has created a wide range of apps related to health and medicine without knowing whether or how those apps would be regulated. Now the Food and Drug Administration (FDA) has issued some guidance about its plans.

The FDA says it won't look at calorie counters and similar apps that aid in personal fitness, but will only regulate apps that function like a medical device, such as an ultrasound. “We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Dr. Jeffrey Shuren with the FDA.

Apps will be approved on a case by case basis, and approval won't require costly clinical trials as long as the apps resemble devices that are already on the market. The FDA has approved approximately 40 apps in the last two years.



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