Software in Medical Devices, by MD101 Consulting

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FDA issues final Mobile Medical Apps Guidance

After two years of gestation, FDA issues final Guidance on Mobile Medical Apps!

The guidance gives the definition of a mobile medical medical app.
Basically, there are 3 categories, an app is a medical device if:

  • it is an extension of an existing medical device,
  • it transforms the mobile platform by using on-purpose peripherals,
  • it performs patient specific data analysis for diagnosis or treatment.

Read carefully the definitions of FDA, those above are summed-up for easy reading.

But these rules are not enough, many apps are borderline as their perform tasks related to patient condition but don't match the 3 above rules.
FDA gives a list of borderline cases in its guidance, like Provide patients with simple tools to organize and track their health information. For these borderline cases, FDA intends to exercise enforcement discretion.

In other words, how can you be sure that the App you develop is not a mobile medical app?
Just ask FDA, or apply the not seen, not taken policy, which I don't recommend!

But the most interesting part is probably in the annexes. They contain a long list of examples that can help you figure out whether your app is a regulated device or not. Especially, FDA gives cases, for which mobile apps are not medical devices.
A lot of cases are covered by these examples. There is actually little chance that an app manufacturer doesn't find a case that matches his app in the list.

More information on FDA news release.

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