The US Food and Drug administration has begun investigating
an iOS medical app available
on the App Store to find out why it wasn't pre-approved by the agency and has begun the process of setting up guidelines for apps that make health- and medical-related claims. Currently, the agency only closely regulates some specific apps tied to medical hardware that would have dire consequences if they didn't work as advertised.
The app in question, uChek
by Biosense Technologies ($40), allows users to check levels of blood, protein or other substances in their urine using test strips and the iPhone camera to record and analyze the results. The app is used mostly by diabetic patients for self-monitoring.
In its letter
to the company that makes the app, the FDA pointed out that the test strips the application uses weren't approved for automated analysis and thus can't be assured of giving correct readings. The agency is planning to adopt stricter rules, such as requiring FDA approval, on apps that directly diagnose or treat conditions.
The letter warns that Biosense may need to obtain agency clearance for the entire system, including the strips: "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," the letter says. "Since your app allows a mobile phone to analyze the dipsticks, the phone and device as a whole functions as an automated strip reader."
"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)."
For its part, Biosense replied with a statement saying it intended 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." The CEO of the India-based company said that it received the FDA letter on Wednesday, but did not say if the strip makers, Bayer and Siemens, had received similar letters. Inquiries to both companies on whether they had gotten letters were not immediately answered.
The FDA has indicated that it is seeking at least a 510(k) application for the app in preparation for a formal approval. The 510(k) doesn't require clinical trials as long as the applicant can prove its product is similar to an already-approved product.
The FDA originally proposed in 2011 that diagnostic medical apps should have the same standards applied to them as mechanical medical devices such as ultrasound machines and heart stents. Depending on how cooperative the company is, the FDA may have to issue a further letter outlining possible legal violations and requesting that the company remove the app until the FDA gives its approval.