The US Food and Drug Administration (FDA) will soon begin testing mobile medical apps before they are allowed to be sold. While the agency currently tests major health care related apps it does not closely monitor all medical apps that are released for public consumption.
FDA officials currently focus on apps that could have life-threatening consequences if they don’t work as advertised.
The question of FDA approval has come about because of an app called uChek. Sold by Biosense Technologies for $40 on the Apple App Store the program checks blood, protein and other substance levels. Customers use test strips and the iPhone camera to record and analyze results. uChek is used by diabetic patients to self-monitor their condition.
Officials at the FDA recently sent a letter to Biosense Technologies and noted that the test strips had not received FDA approval for automated analysis.
While the FDA didn’t pull the plug on uChek it did state that stronger FDA approval with strict rules will be required in the future. The new approval standards will be applied for any application that promises to test or diagnose health issues.
In the letter the FDA writes:
“Please note that though the types of urinalysis dipsticks you reference for use with your application are cleared, they are only cleared when interpreted by direct visual reading. Since your app allows a mobile phone to analyze the dipsticks, the phone and device as a whole functions as an automated strip reader.”
The letter continues:
“When these dipsticks are read by an automated strip reader, the dipsticks require new clearance as part of the test system. Therefore, 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).”
Biosense has taken the responsible route by promising to ”work very closely with the US FDA over the coming months to ensure that we continue to deliver accurate, affordable and convenient diagnostics across the world.”
Biosense has been offered a 510(k) application for the app. That application would allow the FDA to check out the apps results and offer formal approval. That application does not require a clinical trial if uChek can prove that it uses an already available product with similar results.
Do you think the FDA should need to approval medical apps for smartphones and other mobile devices?
[Image via Wired]