The company, which Thompson did not name, apparently puts a disclaimer on its website saying it's not intended to be a medical device. But Thompson said as the app will retail for $20 with the test kit, it's unfair to stand-alone products that do much the same thing, just not on consumer mobile devices, and which have to go through FDA's clearance process.
"Companies that employ a quality system will probably have to charge more than that to make a decent return. How can a company lawfully compete with those that are willing to try to avoid FDA regulation with a simple disclaimer?" Thomspon asked in his written testimony.
"Yes, FDA has not published its final guidance on mobile medical apps. But it certainly doesn't need to publish that guidance to enforce the statute and a 26-year old regulation that requires FDA compliance for a urinalysis test," he added.
