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 "Telemedicine: Mobile App Maker Biosense Receives FDA 'It Has Come to Our Attention' Letter."
Following is an excerpt:
In a letter posted May 21 to the Food and Drug Administration's website, the agency told Biosense Technologies Private Ltd. that its uChek Urine Analyzer might require marketing clearance.
The letter, titled as an "It Has Come to Our Attention Letter," tells Biosense that "[t]he uChek Urine analyzer appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act." ...
Bradley Merrill Thompson, an attorney with Epstein, Becker & Green in Washington, told BNA May 23 that FDA's use of such a letter is unusual. He said, "It is, to my knowledge, the mildest form of enforcement letter."
"My impression is that FDA uses it with companies that are not traditional medical device companies, and therefore perhaps not expected to know as much about FDA regulation. So the letters take a more educational tone. Further, they don't emphatically assume the violation, but rather give the company an opportunity to explain itself," Thompson added.
"I guess that's why FDA used it in this case, although the company really is a classic startup company just like any medical device startup company. But I think here, too, the bigger picture influenced FDA in the sense that they are trying very hard not to scare away app developers from entering mobile health. So they wanted to use a very light touch to signal to other would-be mobile medical app developers that FDA will be as kind and gentle as they can be when a company messes up." Thompson helps lead the mHealth Regulatory Coalition, which has advised FDA on how it believes the mobile apps market should be regulated. ...
"The prior recipients of these letters, and I think there were five or six sent, were all start-up genetic testing companies that again would not be classic medical device companies," he said. "On the whole, I think this is a very positive thing for the mHealth industry. With regard to apps used in higher-risk settings, a lot of medical device companies have been sitting on the sidelines because they don't want to invest a bunch of money and work through the FDA compliance issues, only to have another company come along and sell [a 99-cent] app with no expense for FDA compliance," Thompson said.
Thompson said he expects "this FDA enforcement action to spur investment in higher-risk mobile apps, now that it's clear that FDA compliance will be expected."
