The mHealth Regulatory Coalition released a set of suggestions for the FDA’s medical app guidance on Friday, September 30, 2011. In these comments, the MRC outlined changes that need to be made to mobile app risk assessment, marketing definitions for mobile devices, and classification of mobile device add-ons.
As a means of assessing the amount of risk a mobile app may cause a user, the MRC has created a risk assessment tool in the form of a color-coded matrix that they hope the FDA will find useful. The group claims that the tool can determine the “true risk” of a mobile medical app by comparing how likely it is for the device to fail against the amount of danger posed if the app does fail. The MRC sees this as the most useful means of classifying the application because, although app features are hard to regulate because they change frequently, this tool will capture the functionality of the device.
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