The Food and Drug Administration (FDA) is announcing a public workshop entitled "Evolving Role of Artificial Intelligence in Radiological Imaging." The intent of this public workshop is to discuss emerging applications of Artificial Intelligence (AI) in radiological imaging including AI devices intended to automate the diagnostic radiology workflow as well as guided image acquisition. The purpose of the workshop is to work with interested stakeholders to identify the benefits and risks associated with use of AI in radiological imaging. FDA also plans to discuss best practices for the validation of AI-automated radiological imaging software and image acquisition devices. Validation of device performance with respect to the intended use is critical to assess safety and effectiveness.