Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practices, in the Washington, DC, office, was quoted in an article titled “FDA Shows Deft Touch with 1st Mobile App Enforcement.” (Read full version — subscription required)
Following is an excerpt:
The U.S. Food and Drug Administration’s Tuesday move to rein in a developer of iPhone urinalysis software marked a perfectly balanced foray into stronger oversight of the fledgling mobile medical apps industry, experts say, addressing frustration among app makers that already work closely with regulators while taking care not to scare off potential innovators. ?…
With that in mind, the FDA likely wanted to speak softly in its first enforcement action, delivering a message that compliance is expected without sending software companies into panic mode, said Bradley Merrill Thompson, an FDA specialist at Epstein Becker Green PC who was among the first to sound an alarm over uChek.
“It’s accommodating, and I think the philosophy is that they’re dealing with a nontraditional medical device company … and so they’re trying to be more educational,” he said.
The likely upshot is that the FDA gets the best of all worlds: more safety without appearing to be a bully, and more innovation from companies that want to develop apps but can’t compete if rivals are flying under the radar and avoiding costly compliance, according to Thompson.