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 titled “FDA’s Light Touch with Medical Apps May Let Industry Bloom.” (Read the full version — subscription required.)
Following is an excerpt:
The U.S. Food and Drug Administration’s hands-off approach to mobile medical apps is allowing potentially risky diagnostic tools to be sold to consumers without facing regulatory scrutiny, but stronger enforcement in the short term could stifle a promising and fast-growing field of health care technology, experts say. ?…
Bradley Merrill Thompson, an FDA specialist at Epstein Becker & Green PC, said he’s witnessed a steady stream of apps that claim to offer advanced medical capabilities and are being marketed without FDA approval.
“Honestly, I see them every day,” Thompson said. “Clients bring them to me and complain, ‘Here’s this other guy who’s not doing it.'” ?…
While the app isn’t yet available, Biosense has sent out promotional literature “extolling the clinical uses of its product to monitor disease” while at the same time trying to “simply disclaim FDA medical device status,” Thompson told lawmakers.
That app is a perfect example of the sort of software that should be facing FDA enforcement, but isn’t, Thompson told Law360.
“If someone thinks they might have diabetes and tests their urine and it comes up clean,” that has real consequences, Thompson said. “This stuff is serious. It’s not a video game. Real lives hang in the balance.”