Regulatory Affairs

Office of the Vice President and Innovation

The U.S. Food and Drug Administration (FDA) announced a public workshop entitled “Evolving Role of Artificial Intelligence in Radiological Imaging,” will be held February 25-26, 2020. This workshop is an opportunity for stakeholders to provide feedback to the FDA on the following topics:

  • Emerging applications of Artificial Intelligence (AI) in radiological imaging, including devices intended to automate the diagnostic radiology workflow and enable guided image acquisition;
  • Benefits and risks associated with using AI in radiological imaging; and
  • Best practices for the validation of AI-automated radiological imaging software and image acquisition devices to assess safety and effectiveness.

Key dates:

  • January 10, 2020 – Request to make oral presentations
  • February 12, 2020 – Register to attend the workshop
  • March 26, 2020 – Submit written comments
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