Eye to eye
Industry officials applaud FDA’S mobile medical app guidelines
It’s a rare phenomenon at the intersection of politics and business: The federal government announces plans to create new industry guidelines, and those in the targeted industry say they’re glad to hear it.
That appears to be the case for the U.S. Food and Drug Administration, however, after the agency’s release last week of “draft guidance” for developers of mobile medical applications for smartphones and other mobile devices.
“The use of mobile medical apps on smartphones and tablets is revolutionizing healthcare delivery,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a news release announcing the regulatory advisory. “Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.”
The FDA’s 29-page proposal does not establish legally enforceable responsibilities for app and device developers—though it signals a likely move in that direction. A 90day public comment period on the recommendations is now open.