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FDA Reiterates Intention To Regulate Only A Small Portion Of Mobile Medical Apps

On the last day of hearings by three House Energy and Commerce subcommittees March 19-21, CDRH Office of Device Evaluation Director Christy Foreman largely reiterated FDA’s previously stated approach to regulating mobile medical apps. Meanwhile, Energy and Commerce Committee Vice Chair Marsha Blackburn, R-Tenn., hinted at legislation on the issue

CDRH Office of Device Evaluation Director Christy Foreman testified at a congressional hearing March 21 that FDA still intends to limit its regulation of mobile medical applications to a very small subset.

The largely hands-off approach to the emerging mobile medical app industry was first articulated in a 2011 FDA draft guidance, but the agency's failure so far to finalize the guidance...

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