Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice in the Washington, D.C. office, was quoted in an article about concerns on whether FDA’s regulations will disconnect the medical smartphone app industry.
The article discussed how many in the industry are wondering whether the FDA will soon clamp down on the thousands of health care smartphone apps. And, whether the agency will focus on radiology viewers — where there is clear potential for dangerous misreadings by rushed radiologists on tiny screens — or is the fear of coming regulations doing more harm.
Thompson commented that regulations have actually been fairly light. “I think the FDA, to their credit, has been holding back to study what’s going on, to try to understand the hardware and software and decide what they want to do based on risk,” Thompson said.
He went on to explain that an app advertised as helping people lose weight would probably count as a mere “wellness” program. It would therefore stay well outside the agency’s remit. But if the product were marketed as a way to treat obesity — a disease — then it would be making a clinical claim and could fall under the agency’s scrutiny.
“That’s one of the things I’m preaching: these companies need to be aware of the rules, so when they make their claims, when they put their advertising together and other information that describes the use, they can make intelligent decisions about how they want to manage them,” said Thompson.
“The premarket approval application is a very resource-intensive process of doing clinical trials and providing the clinical safety effectiveness of their products,” Thompson said.
“The pioneer has a tougher row to hoe because they have to basically navigate where there’s no map,” said Thompson. “They have to figure the pathway through the agency and provide a certain amount of data and information to establish the right to market the product.”