Interview: The iPhone medical app denied 510(k)

By: Brian Dolan | Mar 15, 2010        

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What do you think of curious language like “approved for use on iPhone” or “not intended for diagnostic purposes” on other apps’ descriptions?

Honestly, putting “currently approved for use” in a press release about an iPhone medical application, especially in this overly heightened and uncertain regulatory environment, seems misleading and foolish. Sure, it is probably alluding to the approval that Apple gives to put the app on the App Store, but it is worded poorly. Regardless, the FDA is somewhat touchy on using the word “approval” (see Sec. 807.39 and Sec. 807.97).

There is a long history of medical imaging software that has used the “not intended for diagnostic use” disclaimer. I cannot speak for the FDA on this. I can only note that nothing has been done to discourage its use, at least nothing that I am aware of. In the absence of visible action from the FDA’s Office of Compliance, the practice is probably seen as appropriate by those who use it.

What happens next?

We will continue to pursue the necessary legal means to get our product to market.

We have, however, obtained approval to affix the CE marking on the Mobile MIM device by providing evidence to our notifying body that we have met all the essential requirements of the Medical Device Directive 93/42/EEC. Mobile MIM is currently available in the United Kingdom, Australia, Hong Kong, Singapore, and India.

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