Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted on increasing demands among investors in mobile wireless health devices for more clarity on FDA regulations for the industry.
In the article, “Mobile Health Device Field Seeks Regulatory Guidance From FDA And FCC,” Thompson stated that mobile technology makers entering the medical space are concerned about the possibility of burdensome FDA requirements.
“During the early period of technology development, I think it’s a good thing for regulators to hold back,” Thompson acknowledged, but as an industry matures, stakeholders begin to be more interested in the rules.
“I think we’re entering that phase, at least on the FDA side,” Thompson said. “Some don’t want to invest until they hear the rules of the road.”
Thompson, who was speaking to an audience of mobile health software developers and other attendees at the mHealth Networking Conference held Feb. 3-4, in Washington DC, pointed out that it is important for companies to know in advance what it will be dealing with. Because the medical device field relies so heavily on venture capital, investors want to know whether they will be exposed to FDA regulation.
“The venture capital community likes to have some clarity on that front,” he said.