Nice overview article of Grad CAM (Gradient-weighted Class Activation Map) which can be used to generate “heatmaps” highlighting the relevant regions of an image that contributed to the model design.  This can be useful in documenting the “explainability” portion of the model documentation that one will likely need for a regulatory submission.  Read More

Updated: Final guidance released August 25, 2025. View the document: 2025-08-Guidance-Predetermined-Change-Control-AI The US FDA has a continuous challenge trying to ensure that regulations keep up with advancements in technology.  As with any new technology, manufacturers try and make the existing regulations applicable, while FDA assesses whether or not existing regulations are appropriate for the new technology. ...Read More

FDA Draft Submission Guidance AI/ML For Use of AI/Machine Learning-Enabled Device Software Functions Almost every day there is another news story about something involving “artificial intelligence.” So it seems timely that the FDA has just released a draft guidance for Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device...Read More