Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled “FDA Letter on Mobile App May Bring Welcome Clarity to Field.”
Following is an excerpt:
A rare enforcement action against a mobile app developer for failing to get 510(k) clearance may have a positive effect by setting boundaries for the rest of the field, one mHealth expert says.
The app, uChek Urine Analyzer, uses the phone’s camera to read urine dipsticks. The uChek is meant for use with FDA-cleared Siemens and Bayer reagent strips and can read tests for glucose, ketones and protein, among other analytes. But, according to an agency letter to app maker Biosense Technologies, the uChek system was never cleared via 510(k).
The letter, posted to the FDA’s website May 21, states the reagent strips are cleared only for direct visual reading. Because the app allows the phone to do the analyzing, it should be regulated as an automated strip reader and require separate clearance, the FDA reasons.
This appears to be in line with previous FDA promises to regulate only mobile apps that allow smartphones to operate as regulated devices. And that means the letter may help clarify the rules for higher-risk devices, said attorney Bradley Merrill Thompson of Epstein Becker Green and the mHealth Regulatory Coalition. Thompson added that he’s repeatedly made public statements that Biosense’s marketing seemed to cross a line, and the FDA’s letter seems to put that question to bed.
“For decades, FDA has regulated urinalysis, and they are quite clearly saying that such regulation applies whether the machine is the size of a cash register or a simple app that sits on a cell phone,” he said. The clarity may help future developers enter the market “the right way” with proper regulatory approval, he said.