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 ...
The Food and Drug Administration (FDA) Breakthrough Devices Program was created by the Congress in the 21st Century Cures Act of 2016. The program is designed to accelerate the development, assessment ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback