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.
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"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.
