Gottlieb says FDA's traditional approach not well suited . . .

FDA Lays Out Plan To Loosen Regulation Of Medical Device Software

By Beth Wang / July 27, 2017 at 6:37 PM

FDA launched a pre-certification pilot program Thursday (July 27) that will allow technology and software development companies to get pre-certified with the agency, eventually allowing them to “submit less information [to FDA] than is currently required before marketing a new digital health tool,” FDA Commissioner Scott Gottlieb says.


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