Bradley Merrill Thompson Quoted in Article, “7 Takeaways from FDA’s Mobile Medical Apps Guidance”

Law360

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 "7 Takeaways from FDA's Mobile Medical Apps Guidance." (Read the full version — subscription required.)

Following is an excerpt:

The U.S. Food and Drug Administration's release this week of final guidance on mobile medical apps provides much-needed clarity, yet it also leaves big questions unanswered and signals that ramped-up enforcement awaits, experts say. ?...

Bradley Merrill Thompson, a member at Epstein Becker & Green PC and one of the nation's top experts on mobile medical apps, told Law360 that "one of the key issues upcoming will be transitioning from this guidance development phase to an enforcement phase."

During a briefing Monday, Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, signaled that the agency would take an educational approach at first, according to Thompson. ?...

"[Shuren] explained that they do not have an ambition to collect scalps — my word, not his — but rather would like to work with companies that find themselves within the scope of FDA regulation," Thompson said. ?...

"Really, all the guidance document tackles is the threshold question of whether a mobile medical app is regulated," Thompson said. "It does not tackle the subsequent question of, for those that are regulated, how are they regulated?" ?...

"We hear concerns about the amount of ambient light [and] other unique characteristics of the mobile app environment, but we have not seen from FDA any articulation of how that translates into premarket data requirements," Thompson said.