A startup app team has developed an iPhone app called UCheck that analyzes urine strips. These strips are often used by diabetics and for other medical reasons. Typically, strips have to be inserted into a special machine in order to be read, but this app bypasses that additional device.
Instead, UCheck analyzes urine by looking at information gathered from a photo taken of a urine strip -- you snap a picture of a strip, and the app analyzes it. The analysis is really complete too. Everything that you could or would want to know about your urine, you can find out by using the UCheck app. There's just one problem -- the FDA isn't so keen on UCheck.
The FDA Steps In
Generally, the FDA doesn't have much to say in the way of apps. App development isn't really an area that the FDA focuses on, but the UCheck is different. Since the UCheck uses an iPhone as a urine strip reader, the iPhone is considered (by the FDA) to be a medical reading device. Thus, the device (or the app) has to be approved by the FDA.
The FDA has sent the developers behind UCheck a notice stating that the app has to meet FDA approval. You might read this as: the FDA wasn't invited to the app launch party, so the organization isn't very happy about the app. Or, you might say that the FDA has some right to intervene here. Why?
Why The FDA Might Be Justified
There's little doubt that many people will want to use the UCheck app to test urine strips. This is especially true since strips are far less expensive than testing machines, and many people already have an iPhone (or iPod or iPad). But, the FDA has to be sure that the app is accurate. Otherwise, people may be relying on an app that doesn't work exactly right, and this could be dangerous.
On the flip side, the FDA did not state that the app doesn't work in the letter sent to developers. Instead, the federal department simply wants to approve the device. The developers behind UCheck haven't weight in, officially, on the matter yet, but it's pretty hard to fight with the FDA. For now, app developers will simply have to comply or face app extinction.
Getting the App
Interestingly, UCheck is still available for download through the Apple store, so you can get it there. If you use urine strips for any medical reason (or you're just curious about how your urine is looking right now), you can purchase some strips, snap a photo, and let UCheck tell you how you're doing.
Is the FDA justified in telling the UCheck team that it has to go through federal scrutiny prior to releasing the app into the wild? It's really interesting to note that Apple has not removed the app from the app store, and it's also interesting to note that many people are already using the app. Would you use it? I'm betting that a lot of people will find UCheck more than a bit helpful.