IPhone Urinalysis Draws First FDA Inquiry of Medical Apps

[xchrom]

http://www.bloomberg.com/news/2013-05-23/iphone-urinalysis-draws-first-fda-inquiry-of-medical-apps.html

An iPhone application that lets users check levels of blood, protein and other substances in their urine is the first target of U.S. regulators seeking boundaries in a burgeoning industry for medical diagnosis on-the-go.

Biosense Technologies Private Ltd.’s uChek system isn’t cleared by the Food and Drug Administration and the agency said it wants to know why not, in a first-of-its-kind letter to a maker of a mobile-device application. The app relies on users, such as diabetics checking their glucose, to dip test strips in urine and use the smartphone’s camera to allow the system to processes and generate automated results.

UChek works with test strips made by Siemens AG (SIE) and Bayer AG (BAYN), which are only approved for visual reading and require new clearance for automated analysis, the FDA said in the letter. The agency has said it wants stricter rules for apps that directly diagnose or treat conditions, proposing in 2011 to apply similar quality standards as for heart stents, ultrasound machines and other medical devices.

“We intend to finalize the guidance this year,” Synim Rivers, an agency spokeswoman, said yesterday in an e-mail. “The FDA has proposed a regulatory approach that limits its immediate oversight to a specific, small subset of mobile medical applications that are medical devices and present the greatest risk to patient safety if they don’t work as intended.”

[Downwinder]

1. If they certify the app

won't they have to certify the Smartphone, too.

[goldent]

2. I'd think they would need to deal with color accuracy of the camera, including ambient lighting

Perhaps the strip could be photographed on a calibration card. It is not a simple problem, and they need to clearly display the range of error in the output display.

Certification of medical devices can become very complex - in this case it is not as bad because with this class of device there is no direct risk of injury (worst case is misdiagnosis).

If they thought they could just start selling something like this as an Apple app, it makes me believe they aren't too experienced in developing medical devices. I would be worried that they did something fairly naive.

[MannyGoldstein]

3. The FDA has new (sorta) rules on this

Bottom line is they don't, but if they don't then they need to demonstrate that their app is safe and effective even if the the phone does unexpected stuff.