FDA Sends Letter to Mobile App Developer for Failure to Obtain 510(k) Clearance

FDA has issued an “It Has Come to Our Attention Letter” to Biosense Technologies Private Limited for failure to have a 510(k) clearance for its mobile app, the uChek Urine Analyzer.  The app can be downloaded for 99 cents through the iTunes Apps Store, and uses the phone’s camera to read urine dipsticks.  The app is intended for use with the 510(k)-cleared Siemens and Bayer reagent strips for the qualitative and semi-quantitative determination of urine analytes, including glucose, urobilinogen, pH, ketone, blood, protein, bilirubin, nitrite, leukocyte, and specific gravity.

FDA’s letter explains that because the app allows a mobile phone to analyze the dipsticks, “the phone and device as a whole functions as an automated strip reader” that require clearance as a “urinalysis test system.”

The company is being asked to either identify an FDA clearance for the app, or provide an explanation for why Biosense does not believe that the company needs to obtain 510(k) clearance.

This letter is very unusual.  Although the FTC has publicly stated that it believes that there is a need for more aggressive enforcement action against medical apps, enforcement actions against mobile medical app developers have not been at the top of FDA’s agenda.  In fact, according to press reports, FDA has recently said that the agency is being cautious about which kind of enforcement action it takes because there is no clear agency guidance on the regulation of mobile apps.

As we previously blogged, FDA has proposed to exert regulatory authority over select mobile medical apps that meet the “device” definition in the Federal Food, Drug, and Cosmetic Act, and that are either used as an accessory to a regulated medical device, or transform a mobile platform into a regulated medical device.  In this case, it appears that the Biosense app falls in the category of apps for which FDA will apply regulatory oversight.  The Biosense app appears to transform the mobile platform into a medical device by including functionalities similar to those of currently regulated medical devices, such as Acon Laboratories, Inc.’s Mission U500 Urine Analyzer, K111221, which has the same intended use as Biosense’s app.

It is unclear whether this unusual letter is an indicator of a coming increase in FDA’s enforcement action against medical apps.  FDA may have felt the need to issue this letter because of the intense media coverage that the app and the company have received in the past few weeks.

The letter shows that there will continue to be  case-by-case enforcement even as FDA mulls general guidance for mobile apps.  The letter suggests that mobile apps are particularly at risk of enforcement if their functionality is similar to those of currently regulated devices already subject to FDA regulatory oversight.