Bradley Merrill Thompson, Member of the Firm, was quoted in an article during an industry meeting with FDA staffers on mobile health regulatory plan.

Members of the mHealth Regulatory Coalition representing the medical device, wireless communication and software industries met Jan. 10 with more than a dozen FDA staffers to discuss next steps for creating agency guidance on mobile health devices.

"You have to define the problem before you can solve the problem," said Thompson, one of the Coalition leaders.

During the meeting, FDA gave the coalition feedback on the white paper, which outlines open questions on the scope of FDA regulation of mobile health systems.

FDA's concerns were clearly focused on safety risks, Thompson noted.

The agency gave no assurances that it will adopt any particular draft guidance the coalition submits; FDA told the group it is developing content for a guidance internally in parallel with the industry's efforts, Thompson reported.

One concern over mobile health regulation raised by FDA, Thompson said, is that the pace of mobile health technology adoption is so fast that any regulatory approach the agency may take could become quickly outdated.

The mHealth Regulatory Coalition is aiming to complete its draft mobile health guidance to submit to FDA within three months, but Thompson admitted that such a timeline might be optimistic.

"We have our work cut out for us," he said, adding that he and other industry members left the meeting with FDA "feeling a little bit overwhelmed."

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.