Final Rules Issued For FDA-Approved Mobile Medical Apps

October 28, 2013Two years after releasing draft guidance in which the Food and Drug Administration (FDA) proposed regulating any mobile application deemed to be a medical device, new rules have been announced.


In an article attributed to Reuters entitled "U.S. FDA Issues Final Rules On Mobile Medical Apps," Chicago Tribune LIFESTYLES is reporting that the FDA will "focus its oversight on those products that have the potential to harm consumers if they do not function properly."


Salient points in the Chicago Tribune article included:


- The FDA intends to only regulate products that turn smartphones into medical devices already regulated by the agency; for example, electrocardiography machines. The report quotes Dr. Jeffrey Shuren, Director of the FDA's Medical Device Division, "It's not about the platform. It's about the functionality." He added, "An ECG is an ECG."


- The FDA will also regulate accessory applications to a regulated device (e.g., a tablet that displays images used by doctors to make diagnoses).


- The FDA "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," according to the article, or any app that helps users "organize and track their health information, or promote strategies for maintaining a healthy weight or adhering to medication dosing schedules."


The Chicago Tribune points out that the regulated products need FDA clearance prior to being allowed into the marketplace. They report that the agency has OK'd approximately 100 mobile medical apps over the past decade, and that 40 were cleared in the two years since the draft guidance.


Read the full Chicago Tribune LIFESTYLES post here.


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