EMA and FDA have jointly issued guiding principles for the safe and responsible use of AI across the medicines life cycle, aiming to harmonize ...

The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control ...

Though no timeline has been established for publication, FDA intends to issue several related pieces of guidance, including: – Final Guidance from CDRH on Marketing Submission Recommendations for a ...

To support the continued development and marketing of safe and effective medical devices enhanced by artificial intelligence, the U.S. Food and Drug Administration will offer marketing submission ...

There seems to be a modern day gold rush as companies explore how to use machine learning in clinical decision support software. Unfortunately for libertarians, FDA will regulate some of that software ...