'Software is not a medical device': FDA medtech chief battles for control of mHealth

November 21, 2013 by Arezu Sarvestani

FDA medical device chief Jeffrey Shuren spars with the House Energy & Commerce Committee's subcommittee on Health over the FDA's proper role in regulating mobile health and medical applications.

Pitts to Shuren: 'Software is not a medical device'

The conversation got a bit heated this week as the House Energy & Commerce Committee's subcommittee on Health sparred with FDA medical device chief Jeffrey Shuren over regulation of mobile medical and healthcare applications.

Shuren maintained that medical applications should fall under FDA purview regardless of their role in a primarily medical platform or on a mobile device, especially since more medical device makers are developing adjuncts to smartphones and tablets rather than building new technologies from scratch.

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"Manufacturers don't have to make the hardware anymore," Shuren told the subcommittee, chaired by Rep. Joe Pitts (R-Penn.). "That's the way the world is changing."

The FDA in September released its final rule regarding medical applications for mobile platforms, largely taking a hands-off approach and focusing its oversight on a small subset of applications that it deemed risky enough to harm patients if not working as intended. That means the majority of healthcare apps won't be regulated under the FDA's charter, but those strokes were still too broad for some members of Congress who have put their support behind the SOFTWARE Act, seeking to further limit the FDA's oversight of mobile healthcare technologies.