Bradley Merrill Thompson Quoted in Article About Clearance of First Diagnostic Radiology AppFDA Week February 10, 2011
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 "mHealth Backers Applaud 510(k) Clearance Of 1st Diagnostic Radiology App."
According to the article, mobile health proponents are applauding FDA's 510(k) clearance last week of an application allowing physicians to view medical images on certain mobile devices, interpreting the move as a major first step for the agency on mHealth. The agency had initially rejected the 510(k) pathway and called for the device to go through the more stringent premarket approval process, but then reversed that decision.
Thompson said he is hopeful that FDA's action may lead to similar outcomes for other comparable applications. "It's actually huge," he said. "It's a large step in the right direction." He said it is "very encouraging" that FDA backed away from its initial call for the product to go through the PMA pathway.
Thompson said it's particularly important because the clearance should benefit future applicants with mHealth technologies. "Now it's available as a predicate, so the pathway that that company went through is available to all others," he said. "But also, the regulatory pathway ... in a broader sense, is available to companies in this space, so that's very helpful."