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

Thu, 11/21/2013 - 1:56pm
Mass Device

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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