'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.

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