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 Emphasizes 'Deregulatory' Efforts in Mobile Medical Apps Final Guidance."
Following is an excerpt:
FDA will actively regulate only the small portion of mobile medical applications that present the same risks as conventional FDA-regulated devices, the agency affirmed in the much-anticipated mobile apps final guidance issued Sept. 23. ...
Bradley Thompson, a lawyer with Epstein Becker Green who heads the mHealth Regulatory Coalition, told "The Gray Sheet" the group is "delighted" FDA published the guidance within the timeframe promised to Congress. "There is much that is very helpful in this guidance document, and we are 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 said.
However, he said the final guidance is similar to the proposed guidance and still "omits some very important areas." In particular, he said FDA has not addressed the definition of what are regulated, disease-intended uses compared to unregulated, wellness-intended uses, as well as the exact meaning of an "accessory to a medical device," in the final guidance. "But we also understand that FDA is working on those two topics separately, so we look forward to seeing what the agency comes up with," he added.
Thompson was also enthusiastic about FDA's intention to take and post comments dynamically online, calling it "perhaps the best news of the day." He wrote in an email, "This is incredibly important, because the mobile app world is changing so quickly that the notice and comment style of guidance development could not possibly keep up." ...
"An awful lot of the language in the final guidance document is new; which means it has not been publicly vetted before," Thompson wrote. "While much of it is carefully written, some of it is subject to interpretation and a bit confusing. I'm sure these issues will get worked out; they don't seem to be very fundamental." He specifically noted one change from the draft that his group is happy with: FDA expanded its section on borderline apps that might qualify as a medical device but were nevertheless exempted. ...
While Thompson's mHealth Regulatory Coalition pressed for an expedited release to clarify FDA's policies to developers, other contingents in the health information technology space had urged FDA to hold off on the guidance until a broader set of health IT recommendations can be compiled by FDA in conjunction with the Office of the National Coordinator for Health IT and the Federal Communications Commission. ...
Thompson noted a "clear intention" from FDA "to solicit further input after the first of the year when they have completed the agency discussions," and called the decision from FDA to separate mobile apps issues and clinical decision support issues "appropriate." Thompson and other stakeholders have unveiled a potential proposal for regulating clinical decision support software; they delivered their framework to FDA Sept. 6.
