The application certainly looks extremely convenient: purchase the commercially-available urinalysis strips and the uChek kit, dip the strip in a cup of your urine, insert the strip into a slot in the kit's reference card, place it in the "Cuboid" box, and photograph it with your iPhone. The app takes the analysis from there. An obvious innovation in this era of more and more personalized medicine!
There's an issue, however. In March, regulatory legal expert Brad Thompson wrote a piece for MD&DI Online (Wanted: FDA App Enforcement) asking whether this system is in fact a medical device and subject to FDA clearance. In a separate piece, Thompson went on to make the case (Brad Thompson: Three reasons FDA’s enforcement helps mobile health) that clearer, more consistent FDA action on mobile applications which clearly class as medical devices will actually help spur growth in this area.
Since those pieces were published, the FDA has indeed contacted Biosense Technologies with an "It has come to our attention" letter (FDA Letter to Biosense Technologies), noting that the application qualifies as a medical device, that clearance to market in the U.S. is therefore required, and that the FDA cannot find any clearance number for this application on file. The agency letter also notes that:
though the ... urinalysis dipsticks ... are cleared, they are only cleared when interpreted by direct visual reading ... any company intending to promote their device for use in analyzing, reading, and/or interpreting these dipsticks need to obtain clearance for the entire urinalysis test system (i.e., the strip reader and the test strips, as used together).
In another setting, I've been involved in an exchange of comments over whether the FDA can, in fact, do anything about the uChek app. Biosense Technologies has merely posted the app on Apple's App store, and the urine strips come from another company - the only element they would need to ship to U.S. customers is the kit with the cuboid and the reference card. That, indeed, may be the only leverage the agency has in this situation.
The bigger issue, in my mind, is whether mobile app developers with a cool idea need to follow the same rules as everyone else. What sort of software validation has Biosense Technologies carried out on the application? Have they conducted any kind of usability testing to determine how average individuals might be able to misuse the system and obtain incorrect results? Do they even have any kind of quality system?
Certainly, Biosense has published performance data for their system - but their entire study consisted of (a) reading a series of positive and negative controls, and (b) comparing their system against a commercial urine-dipstick reading system on serial dilutions of a control urine. This is certainly a good start - but when I worked in clinical diagnostics, those studies were only the opening rounds of much more extensive analytical evaluations. Where, for example, is their multi-patient correlation data?
Mind you, the FDA itself is still working through the kinks in this topic. In a remotely-delivered talk at the Wireless Convergence Summit 2013, as reported by MD&DI (FDA's Regulation of Mobile Medical Apps Will Probably Confuse You) FDA's Bakul Patel noted that the agency will "regulate smartly" in the mobile app field. General-purpose apps such as electronic textbooks will not be of interest, while "... apps that are used as an accessory to an already regulated medical device, [or] apps that transform a mobile device into a regulated medical device" will be subject to scrutiny. He also noted that app distributors - the Apple app store or the Google Play Store - will not be subject to FDA regulation, even though they are clearly serving as distributors for a medical device.
Lots of questions remain, as the MD&DI article points out. "How will FDA regulate mobile apps sold overseas? What if an app doesn't meet approvals, but is distributed anyway? Will Class I, II, III be applied to apps?" I'll add my own question here: what happens if a field action or recall of such an app is necessary? We'll have to wait until later this year for some word from the FDA, when their updated guidance on mobile apps is published.
What do you think? Can the FDA do anything about apps developed overseas and posted on one or both of the app stores? Should it pursue the companies that develop these apps if they walk, talk, and quack like medical devices? In a clearly global economy were bitstreams flow rapidly across borders, is there some more rational way to assure reliability and safety of these apps?