The FDA limited the guidelines only to certain defined mobile medical apps that are able to do the following:
• Displaying, storing or transmitting patient-specific medical device data in its original format.
• Controlling the intended use, function, modes or energy source of the connected medical device.
• Transforming or making the mobile platform into a regulated medical device.
• Creating alarms, recommendations or creating new information (data) by analyzing or interpreting medical device data.
A Reuters report indicated that apps that allow physicians to view X-rays or MRIs on a smartphone or tablet are examples of the above that could fall to regulation.
However, the FDA clarified that regulations are not final and are only recommendations at this stage. Comments and suggestions regarding the draft can be submitted within 90 days.
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