ARTICLE | Politics & Policy
FDA launching new digital health regulatory framework
January 7, 2019 8:21 PM UTC
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...