Lawmakers Push FDA To Finalize Mobile Health App Rules

Law360, Washington (March 19, 2013, 3:21 PM EDT) -- Members of the House Energy and Commerce Committee and mobile health application industry on Tuesday criticized the U.S. Food and Drug Administration for stalling the release of its mobile medical application regulatory guidelines, saying the agency has left both developers and doctors in considerable regulatory uncertainty.

Although the agency released its draft guidance back in July 2011, smartphone medical application developers, doctors and consumers still don't know what mobile apps could fall under FDA's medical device regulatory scheme. That uncertainty has hampered innovation in the industry,...
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