Bradley Merrill Thompson Quoted in Article, "FDA Tangles with Wireless Medical-App Makers"
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 "FDA Tangles with Wireless Medical-App Makers," written by Brett Norman.
Following is an excerpt:
An onslaught of mobile health technology has forced an arranged marriage between smartphone app makers and the Food and Drug Administration — because someone had to regulate them…
Bradley Thompson is an attorney who works with the mHealth Regulatory Coalition, which is pushing FDA to relax some of its proposed restrictions on health-related apps. "We get calls from consumer electronics firms all the time, where speed is everything. … I spend a huge amount of time explaining what it means to be in regulated territory, what it means to be FDA-regulated."
But the marketing and other issues — including whether an app that is used with a medical device is automatically a medical device "through guilt by association" — have led to the showdown, Thompson said…
Thompson expects FDA to announce it will do that later this spring or in the summer, while providing final guidance on the general points of agreement.
Areas of Focus