FDA Urged To Issue New Draft Guidance On Mobile Medical Apps

The mHealth Regulatory Coalition wants FDA to release an updated proposed guidance as soon as possible on regulating mobile medical applications.

The mHealth Regulatory Coalition is asking FDA to release an update of its July 2011 draft guidance on mobile medical applications regulation, before it issues a final document, to give the public another opportunity to provide feedback on needed changes.

The agency aims to draw a line between mobile software applications that face regulation as medical devices and those health...

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