Bradley Merrill Thompson Quoted in Article, “FDA Final Mobile Medical App Guidance Mirrors 2011 Draft”FierceMobileHealthcare September 23, 2013
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 Final Mobile Medical App Guidance Mirrors 2011 Draft."
Following is an excerpt:
After a more than two-year wait, the U.S. Food and Drug Administration today issued its final guidance on mobile medical applications, according to an announcement from the regulatory agency. Going forward, the FDA states that it will take a "tailored approach" to mobile medical apps that "supports innovation while protecting consumer safety." ?...
In an email response to a query from FierceMobileHealthcare, Bradley Merrill Thompson, who serves as general counsel for the mHealth Regulatory Coalition, said the organization is "absolutely delighted that FDA published this guidance" in accordance with the timeframe--by the end of fiscal 2013--promised to Congress.
Nevertheless, Thompson said that while "there is much that is very helpful in this guidance document," and while MRC is "particularly pleased that FDA is looking for innovative ways to communicate on a more ongoing basis the kinds of technologies that are regulated, and the kinds that are not," he is disappointed that "the final guidance is fundamentally like the proposed guidance, and omits some very important areas."
According to Thompson, those omissions in the FDA's final guidance include: the definition of what are regulated; disease intended uses compared to unregulated, wellness intended uses; and the exact meaning of an accessory to a medical device. However, he said it was his understanding that the FDA is "working on those two topics separately so we look forward to seeing what the agency comes up with."