Pre Cert Pilot Program News Today

In our last post, we took a brief look back through history at FDA's approach to regulating medical device software and found that there is little distinction from the agency's approach to hardware devices.

FDA announced several digital health initiatives aimed at improving the agency’s resources and policies governing software and data systems. We will review FDA’s digital health improvement highlights and take a quick look at AI/ML-enabled medical devices.

In our last post, we took a brief look back through history at FDA’s approach to regulating medical device software and found that there is little distinction from the agency’s...