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 Plans to Use Enforcement Discretion on Low-Risk Mobile Apps."

Following is an excerpt:

FDA laid out a more hands-off approach to its regulation of mobile medical applications in finalized guidance issued Monday (Sept. 23). The agency plans to regulate only those applications with functions similar to medical devices currently under FDA's purview and use enforcement discretion on other low-risk applications, the agency's top device official said. Issuance of FDA's final mobile medical applications guidance comes on the heels of the publication of recommendations from a federal health information technology working group for a tri-agency, risk-based HIT framework and the FDA guidance tracks with the group's suggestions for the agency to establish a policy of enforcement discretion and focus on the function of the applications. The agency plans to address other issues, like its regulation of clinical decision support software, in report that will be submitted to Congress in January. ?...

But Bradley Merrill Thompson, another member of the workgroup and general counsel to the mHealth Regulatory Coalition, said the agency also omitted other areas of key interest to stakeholders like providing a definition of an FDA-regulated mobile app, a description of the intended use for a regulated mobile app in comparison to unregulated medical apps, an explanation of what the agency would consider to be a wellness intended use, and also the exact meaning of an accessory to a medical device.

The guidance also creates an "interesting problem" in that it includes a lot of new language that has not been publicly vetted. While much of it is carefully written, some of it is subject to interpretation and is a bit confusing, Thompson said. Yet, he said he was confident those non-fundamental issues could be worked out and was generally pleased with the guidance.

"Overall, today is a good day," Thompson said. "The mHealth developers will benefit from having the clarity that this document creates. We all will benefit from FDA's efforts to deregulate a very substantial chunk of mobile apps that might otherwise have qualified for FDA regulation."

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.