12:21 PM
Jan 07, 2019
 |  BC Extra  |  Politics & Policy

FDA launching new digital health regulatory framework

FDA Monday announced the launch of a new streamlined regulatory framework for digital health devices.

The framework will initially be used only for products FDA classifies as software as a medical device (SaMD), which includes software intended to be used for a medical purpose and that is not part of a hardware medical device. It could be expanded in the future to include all medical device software, FDA stated.

The agency plans to streamline its existing de novo novel device review pathway. FDA said...

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