In April 2023 FDA published its Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions Draft Guidance. There has been much discussion regarding the scope and implications of the draft guidance, and FDA has been actively reviewing...

More info coming soon! Times and topics subject to change.

Struggling with determining the regulatory pathways for your device in China? Which pathway needs clinical evidence? Is clinical trial needed to support your device registration in China? This webinar provides an overview of the critical elements of China's registration and clinical pathways, focusing on the...