Guidance for Mobile Medical Apps

This article published with permission from The Burrill Report.

Mobile apps for the diagnosis, prevention and treatment of disease should be treated as medical devices and regulated as such, according to draft guidance the U.S. Food and Drug Administration issued this week.

“Consumers are utilizing these tools almost as quickly as they can be developed,” says Bakul Patel, a policy advisor in FDA’s Center for Devices and Radiological Health. “The agency plans to work closely with application developers and manufactures so they can clearly navigate the best path to market for their technologies.”

The market for mobile medical apps, ranging from sleep monitors for consumers to electrocardiogram viewers for doctors, is growing quickly, with as many as 500 million smartphone users worldwide expected to use health care apps by 2015, according to the consulting firm Research2Guidance.

Mobile medical apps on smart phones and tablets will revolutionize health care delivery, says Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

“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,” he says.

The developers of countless tracking apps for dieters, joggers and expectant moms need not worry, yet. Mobile apps used only to log, record, track, evaluate or make decisions or suggestions related to developing or maintaining general health and wellness are not targeted by the draft guidance, nor are medical textbooks and other reference tomes.

The guidance is primarily concerned with apps that could potentially pose medical risks. That includes apps used as an accessory to a regulated medical device or to transform a mobile platform into a regulated medical device.

“We’re looking at oversight, which does not necessarily mean that all applications would have to go through pre-market review,” says Patel. “It may be that a majority of (apps) do not have to go through pre-market review."

However, an app used to interpret radiological images on a mobile device would be subject to review the guidance suggests because readings could be hampered by the devices’ smaller screen sizes, lower contrast ratios, and uncontrolled ambient lighting during use.

The FDA first issued a draft software policy in 1989, but abandoned the guidelines in that document when it became clear that an overarching software policy to address all the issues related to the regulation of all medical devices containing software was impractical. In the interim, 11 mobile medical applications have achieved 510(k) clearances from the agency, according to a tally by MobiHealthNews.

With the new guidance on mobile apps now published, the agency is soliciting public comments to shape its positioning for what it clearly anticipates will be a new wave of applications for the approval of apps to come.Copyright 2011 Burrill & Company. For more life sciences news and information, visit Burrill Report.