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 “Developers, IT Groups React to FDA’s Mobile Health App Guidance.”
Following is an excerpt:
Bradley Merrill Thompson—general counsel for the mHealth Regulatory Coalition—said the group is “absolutely delighted that FDA published this guidance” before the end of fiscal year 2013, as the agency had promised lawmakers.
Thompson said the coalition is “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.”
However, he said MRC is disappointed that “the final guidance is fundamentally like the proposed guidance, and omits some very important areas.”