The Food and Drug Administration has taken its first action against a mobile app maker for failure to obtain pre-marketing clearance. Late last week the FDA sent a letter to Biosense Technologies Private Limited, asking the company to either identify an FDA clearance for its uChek urine analyzer app or explain why it does not believe that FDA clearance is required. According to the FDA, the uChek app, which allows users to check urinalysis results by taking photos of test strips, and a mobile phone function together as an automated strip reader that requires 510(k) clearance as a “urinalysis test system” because the app allows the phone to be used to analyze the test strips.
Nearly two years ago, the FDA issued draft guidance to inform mobile app manufacturers, distributors, and other entities of its intent to regulate certain mobile medical apps: those that (1) meet the definition of “device” under the Federal Food, Drug, and Cosmetic Act, and (2) are either used as an accessory to a regulated medical device, or to transform a mobile platform into a regulated medical device.
The FDA has apparently concluded that the uChek app transforms the mobile platform into a regulated medical device. The FDA letter points Biosense to a similar urine analyzer that already obtained 501(k) clearance. Biosense told Bloomberg that it plans to obtain FDA approval for the uChek app.
It is rumored that the FDA’s final mobile app guidance will be issued in the coming months. But the FDA’s letter to Biosense suggests that the agency may continue to question mobile medical apps even before publishing those rules.