The Food and Drug Administration (FDA) is announcing a virtual public workshop on transparency of Artificial Intelligence/Machine Learning (AI/ML)-enabled medical devices to patients, caregivers, and providers. The role of transparency that enhances safe and effective use of AI/ML-enabled medical devices will be discussed, with an emphasis on information sharing methods such as labeling. 

The purpose of the workshop is to 1) identify unique considerations in achieving transparency for users of AI/ML-enabled medical devices and ways in which transparency might enhance the safety and effectiveness of these devices; and 2) gather input from various stakeholders on the types of information that would be helpful for a manufacturer to include in the labeling of and public facing information of AI/ML-enabled medical devices, as well as other potential mechanisms for information sharing.