The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device ...
Every year, the media informs us that we’re on the cusp of the golden age of something. While the expected trend often comes to fruition, it’s rarely as smooth a process as advertised. Drug discovery ...
Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a ...
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