FDA has published guidelines for mobile medical application. This guidance would help FDA scrutinize more on software that claim to turn mobile instrument into medical device.
Purpose of the new guidelines is to address the concern of functionality of medical devices. In guideline FDA gave an example of differences in result of radiological image done with mobile of different screen size. These guidelines would eventually help accuracy of diagnosis. FDA has outlined various definitions of terms such as 'mobile medical application', 'mobile platform' and 'mobile application'.
FDA wants to clear passage for applications that are intended for medical usage but will not risk patients' life if it produces wrong data. That is the reason guidelines have exempted medical reference materials, medical textbook, patient information (such as calorie counter) and app with functionality of medical office.
"Mobile medical app is revolutionary aspect in healthcare industry." said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, in a statement.
Digital healthcare industry has welcomed the guidance.
With this first step FDA has classified mobile medical app in two groups, one is harmful when app fails and another is non-harmful app even if it fails. The step is believed to be significant when world is changing rapidly. Next, FDA would probably come up with more detail guidance for the app that pose risk to one's health if it fails to work as intended.
Purpose of the new guidelines is to address the concern of functionality of medical devices. In guideline FDA gave an example of differences in result of radiological image done with mobile of different screen size. These guidelines would eventually help accuracy of diagnosis. FDA has outlined various definitions of terms such as 'mobile medical application', 'mobile platform' and 'mobile application'.
FDA wants to clear passage for applications that are intended for medical usage but will not risk patients' life if it produces wrong data. That is the reason guidelines have exempted medical reference materials, medical textbook, patient information (such as calorie counter) and app with functionality of medical office.
"Mobile medical app is revolutionary aspect in healthcare industry." said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, in a statement.
Digital healthcare industry has welcomed the guidance.
With this first step FDA has classified mobile medical app in two groups, one is harmful when app fails and another is non-harmful app even if it fails. The step is believed to be significant when world is changing rapidly. Next, FDA would probably come up with more detail guidance for the app that pose risk to one's health if it fails to work as intended.
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