FDA “It Has Come to Our Attention” Letter on Medical App

There are Warning Letters, Untitled Letters, otherwise known as Notice of Violation Letters, and now there is the “It Has Come to Our Attention Letter”.  I have to admit, I had not heard of this particular kind of letter before, but one was sent this month the maker of a medical app that performed the task of urine analysis.  I did end up finding a few other examples, however, this was the only one I found that was actually had that as a title at the top –  “It Has Come to Our Attention Letter”.

In any case, this “It Has Come to Our Attention Letter” – hereafter IHCOAL – raised the fact that FDA became aware of the existence of an app that served as a device allowing one to perform one’s own urine analysis with the assistance of a smart phone.  It apparently works by using the phone app in conjunction with re-agent strips – or dipsticks – the app reading the dipsticks to provide the analysis.

In the letter, FDA stated that while the dipsticks have been cleared for use, they have been cleared when used for a direct visual reading of the results.  In using the app to read the dipsticks, it was FDA’s position that the app along with the phone was functioning as an automated strip reader.  “When these dipsticks are read by an automated strip reader, the dipsticks require new clearance as part of the test system.”  In that case, then FDA said there needs to be clearance for the whole new system of analysis – the app used in conjunction with the strips.

So – three lessons.

  • First, the days when your phone was just a phone are long gone and one can expect to see apps doing things that put more ability in the hands of patients to work without a learned intermediary.
  • Second, in the wake of issuing its Draft Guidance on Mobile Medical Applications, FDA has shed further light on its regulation over medical apps with this letter.
  • Third, there is such a thing as IHCOAL letters!

What next for my phone???

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