JD Supra

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations ...
JD Supra

FDA Issues Draft Predetermined Change Control Plan for Machine-Learning-Enabled Device ...

On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial ...