To many people, including especially those who are not familiar with FDA's medical device regulations, reading the new MDDS rule is a bit difficult. We all like to read stories that have a beginning, ...
This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...
In January 2022, the U.S. Food and Drug Administration (FDA) released finalized guidance on premarket pathways for combination products. While the guidance is not binding, it provides industry ...
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