mHealth Group Urges FDA To Publish Final Guidance

Some mHealth advocates are getting impatient with the U.S. Food and Drug Administration.

The FDA released its preliminary guidelines for the regulation of mobile medical apps in late 2011, and since then the mHealth world has been awaiting the government agency's final document. At the Wireless-Life Science Alliance's Convergence Summit this past May in San Diego, Bakul Patel, policy advisor for the FDA's Center for Devices and Radiological Health, wouldn't set a date, but assured attendees that "we are in the process of publishing the guidance as soon as we can."

Bradley Merrill Thompson would like them to speed things up a bit. Thompson, an attorney with the Washington-based law office of Epstein Becker & Green and member of the mHealth Regulatory Coalition, has fired off a letter to Health and Human Services Secretary Kathleen Sebelius asking that the final document be published "as soon as reasonably possible."