The U.S. Food and Drug Administration has issued final rules governing the development of mobile medical apps, saying it will focus its oversight on those products that have the potential to harm consumers if they do not function properly.
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The rules, announced on Monday, come more than two years after the FDA released draft guidance in which it proposed regulating any mobile app deemed to be a medical device.
The FDA said it will only regulate products that transform smartphones into devices the agency currently regulates, such as electrocardiography (ECG) machines that can determine whether a patient is having a heart attack.
The agency will also regulate apps that would be used as an accessory to a regulated device, such as one that displays images used by physicians to diagnose patients.
The agency said it will not regulate the sale or general consumer use of smartphones or tablets or mobile app distributors such as the iTunes store or Google Play store. Nor will it regulate personal wellness apps such as pedometers or heart-rate monitors.
Dr. Jeffrey Shuren, director of the FDA's medical device division, said on a conference call with reporters that whether the agency regulates a product will depend on its function and its risk. If a heart device used in a hospital is currently regulated, chances are a mobile app will be too.
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"It's not about the platform. It's about the functionality," Shuren said. "An ECG is an ECG."
Such products will need to be cleared by the FDA before being allowed on the market. The agency has cleared about 100 mobile medical apps over the past decade, of which 40 were cleared in the last two years. Shuren said the average review time was 67 days.
The agency said it is not going to enforce its powers on mobile apps it considers relatively safe such as those that help patients organize and track their health information, or promote strategies for maintaining a healthy weight or adhering to medication dosing schedules.
According to a report published in March by research2guidance, a research firm, the market for mobile health apps will reach $26 billion by 2017. Currently, there are about 97,000 mobile health applications in major app stores, the report said.
(Reporting by Toni Clarke in Washington; Editing by Leslie Gevirtz)