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 "Time May Be Ripe for FDA Focus on Apps, Expert Says."
Following is an excerpt:
An FDA warning letter last year to Biosense Technologies was a heads-up to mobile app developers, but "the fears of the mobile app industry ?... that the letter to Biosense represented some new trend of aggressive FDA enforcement" have not come true, one expert says.
"Instead, to their credit, I think the agency has held back while companies study the [final mobile medical apps] guidance and make their plans," Bradley Merrill Thompson of Epstein Becker Green told D&DL. "The agency did not act rashly and pursue a whole bunch of app developers, even though frankly they could have." ?...
"I think many of the ethical companies are now waiting for FDA to become more diligent in enforcing the rules," the attorney said. "It does create a tremendous unlevel playing field for ethical companies when they go to the trouble, expense and delay of complying with FDA regulations, and others do not. So I actually think now is the time for FDA to step up enforcement a bit on some of the more egregious violators." ?...
Thompson noted that there are new issues arising as new companies unfamiliar with FDA requirements start marketing their products. For example, some are attempting to presell medical devices, which is illegal.
"Companies that are newer to the space seem slower to learn that. ?... it will be very interesting to see what FDA does with regard to the issue of preselling," he said.
