Bradley Merrill Thompson Quoted in Article, “Will FDA Finally Make the Call on Mobile Medical Apps?”

Medical Device and Diagnostic Industry

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 "Will FDA Finally Make the Call on Mobile Medical Apps?"

Following is an excerpt:

When it comes to apps and mobile phones, speed is everything. Unfortunately, FDA can't keep up. The sector's fast pace of innovation and product development stand in stark contrast to the snail's pace of progress on final guidance for the regulation of mobile medical apps (MMA). But with innovation at stake, patient safety at risk, the FDASIA Workgroup's recommendations in, and the deadline for final MMA guidance looming, it's time FDA provided a clear pathway and picked up the pace. ?...

Bradley Merrill Thompson, partner at Epstein Becker & Green, cochair of the FDASIA Workgroup's regulation subgroup, and upcoming speaker on the subject of medical app regulation at MD&M Minneapolis, echoes this frustration. "[These groups] seem to want to freeze all forward progress at the agency until they've had time to get Congress to pass legislation that would presumably alter the landscape. I think that's very shortsighted." ?...

"There are dozens—if not hundreds—of mobile apps that are on the market now that should have gone through the FDA clearance process," Thompson states. "As to whether or not they're dangerous or not, no one knows, right? The point of FDA review is to validate and make sure that products aren't dangerous." ?...

"Even if a company understands it will be regulated, it doesn't want to enter the space so long as FDA is not actively enforcing the rules against those entering without observing FDA standards," Thompson says. "If FDA's letting everyone go through, someone else could not pursue that costly activity and come to market with a 99-cent app and undercut [the legitimate company]."