mHealth Applications in FDA Crossfire

It was just a matter of time, I guess, but we’ve got the first bit of FDA intervention for a mobile app.  A mobile app maker received a letter from the FDA requiring the app to be removed for sale and to submit for clearance based on what it does.

We’ve had loads of apps lately (some I’ve recently written about) that have medical aspects: HRM, weight, blood pressure, etc., but none of those have required any sort of clearance from the FDA as the types of measurements and style of measuring was not restricted in any way.

So what’s the catch?  And can we expect to see it more often?  Absolutely we can.  The catch is that this particular app in question takes a picture of a urinalysis dipstick and does an automated read to report protein, sugars, etc. in urine.  The same physical strips require no clearance if you read them with your eyes, but if you want your smartphone camera to read them for you… the FDA says they must clear the app first.

So as not to turn it into a political issue, we’ll eschew the right and wrong of it and more focus on the outstanding nature that is the following: mobile phones and interest in health apps have become so pervasive that a previously unknown mobile app maker can simply walk into the crossfire of FDA regulations using nothing more than an easily accessible, already used medical tool (the dipstick) and a smartphone camera that is so advanced it can provide the same, or more accurate, analysis as the human eye.

What’s next?

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