When Is An App A Medical Device?

In an article by Medical Device and Diagnostics Industry online (mddi online), writer Maria Fontanazza, which can be found here, she raises the issue of how the burgeoning number of mobile health technologies should be classified in view of their medical applications. The problem arises because the smartphone/tablet/app revolution requires a fundamental change of definition. What was a piece of kit not originally intended as a medical device, the smartphone, is now becoming one…sometimes.

“[There’s] a bit of friction as everyone gets their heads around FDA and the mobile application developers—how they move forward and produce innovative products while making sure they’re meeting the safety standard for medical devices,” says Brent Melson, director of technology services and development at Intertek.

It’s interesting isn’t it? Last year, the car that can perform some mhealth functions was mooted, with the obvious question as to when a car becomes a medical device.

Medtech industry body Advamed has waded into the discussion with a plea for plain language and one can see why because it’s a potential minefield of ever more convoluted definitions.

One contributor to this piece suggests that if an app has the specific function of diagnosing a medical condition then it should be considered a medical device, which would helpfully distinguish it from popular health apps for fitness and dieting in which the sole function is to log, track, record, evaluate, or make decisions or suggestions for general health and wellness.

But that leaves a yawning chasm of hardware/software combinations which are at the heart of the problem identified in the article. Is the 99C iStethoscope Pro mentioned in another medlatest article therefore a medical device by definition or exempted because the supplier sells it for entertainment? Obvious answer I suppose, but go up the tree a bit and it all becomes a little less obvious.

Not to mention the timeframe clash discussed at the end of the piece, in which the time to market for an app may be days, weeks or even as long as a few months, while the time taken to go through the approval process may be years.

Source: mddionline, medlatest staff