FDA to regulate mobile medical apps

On July 19 the US
Food and Drug Administration announced its intentions to begin regulating the thousands of medical apps for mobile devices that are on the market, but only if they interact with medical devices already regulated.

The FDA regulations are still under development, and the agency is seeking feedback and comments from the industry and general public over the next 90 days before releasing final recommendations.

"It is the manufacturer of the app's responsibility to ensure safety & effectiveness," the FDA noted on a Twitter chat on July 19.

For now, the FDA won't regulate medical apps such as calorie counters or smoking cessation apps, or app versions of medical textbooks or other teaching tools.

But the agency aims to keep an eye on apps that transform your tablet or smartphone into a medical device by using attachments, display screens, or sensors, such as those that collect glucose readings or turn a mobile device into an electronic stethoscope. Also included: apps that use algorithms based on user data to offer health or treatment recommendations, and those that allow users to view medical images for diagnosis.

According to PCWorld, the wireless industry supports the proposed FDA regulations, with the International Association for Wireless Telecommunications, a wireless industry group, voting in favor of the regulations.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm263340.htm

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