FDA's Shuren: Agency to issue mobile app guidance this year

March 14, 2011 by MassDevice

The Food & Drug Administration is planning to release guidance for mobile medical applications in 2011, according to Center for Devices and Radiological Health director Dr. Jeffrey Shuren.

Mobile medical application

By Stewart Eisenhart, Emergo Group

At a Food & Drug Administration town hall meeting held March 10 in Irving, Texas, Center for Devices and Radiological Health director Dr. Jeffrey Shuren disclosed to Emergo Group officials in attendance that the agency plans to issue guidance on mobile medical applications later this year.

Manufacturers have thus far received little official guidance from the FDA regarding how the CDRH would handle mobile medical applications. Although some medical devices incorporating mobile applications have already been cleared by the FDA — GE's Pocket Viewer, Airstrip Technologies' Airstrip, Mobisante's MobiUs and MIM Software's Mobile MIM, for example — no high-level evaluation criteria have yet been issued by the regulator regarding these products.

According to information provided by FDA officers at the town hall, software validation will be required for mobile medical applications. Whether such devices would have to go through 510(k) or pre-market approval processes, or be ruled 510(k)-exempt — has not yet been determined, they said.

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As mobile application and medical device technologies will only converge at a steadier rate going forward, the FDA's pending guidance on this industry-changing trend should prove highly influential in both how manufacturers devise mobile capabilities and how other regulators develop their own approaches to such devices.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.