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 “99 Cent Urinalysis App Raises Questions About mHealth Standards.”
Following is an excerpt:
The uChek urinalysis app made a splash last month with its launch in the iTunes App Store, but it did not appear to follow the same pre-market requirements as analogous conventional urine analyzers, contributing to questions about mobile health regulatory oversight and innovation.
In situations like this, “the whole device gets regulated at the highest classification applicable,” Bradley Thompson, an attorney specializing in FDA device regulations, told “The Gray Sheet.” Even if Biosense does not sell the strips, its clinical claims include use of the test strips, Thompson explains. ?…
“Why on earth would FDA require one company to file a submission on the instrument simply because they also made the test strips, and let another company go directly to market with supposedly the exact same instrument functionality?”
Thompson asks. ?…
It is particularly interesting that Thompson is critical of Biosense’s regulatory approach for the app, since he runs the mHealth Regulatory Coalition, which advocates for the mHealth industry to FDA and other regulators. While Thompson and the coalition are pushing to ensure regulations for mobile apps are not overly burdensome, he argues that it is not helpful for the future of the industry for apps to get to market employing a lesser standard than comparable conventional devices.
“On the one hand, I’m excited [by the potential of apps] like everyone else,” Thompson said in an interview. “But on the other hand, these guys are rushing to the market without going through the process that all the other companies, whether they’re traditional device companies or whether they’re other app companies would follow, if they’re trying to observe the FDA requirements.”
Once on the market, Thompson feels the agency is ignoring those apps that may be violating its regulations. That restraint, while well-intentioned, ultimately hurts innovation, Thompson argued, “The companies that want to go into those areas are not going into them, either because someone’s already occupying the space who’s not complying with FDA and doing it on the cheap; or there’s at least a very good risk that someone will do that in the future.”