Page 2 - Enabled Device Software News Today

The U.S. Food and Drug Administration (FDA) is continuing its effort to provide industries with updated guidance for digital health technologies. On April 3, 2023, the FDA released...

FDA published groundbreaking draft guidance concerning use of artificial intelligence machine learning in medical devices. FDA attempt to provide support for the development of safe and effective medical devices that use machine learning enabled device software functions

On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial...