Bradley Merrill Thompson Comments on Mobile Health Regulatory Plan

The Gray Sheet

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The agency gave no assurances that it will adopt any particular draft guidance the coalition submits; FDA told the group it is developing content for a guidance internally in parallel with the industry's efforts, Thompson reported.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of mobile health technology adoption is so fast that any regulatory approach the agency may take could become quickly outdated.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."