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.  This involves FDA collecting data to inform whether new and/or creative...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 So it seems timely that the FDA has just released a draft guidance for Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device...Read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