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.

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.