On Nov. 15, 2021, The American College of Radiology® (ACR®) filed written comments with the U.S. Food and Drug Administration (FDA) to correspond with the ACR’s verbal presentation at the FDA’s Transparency of Artificial Intelligence (AI)/Machine Learning (ML)-enabled Medical Devices virtual workshop held Oct. 14.
To date, hundreds of AI/ML-enabled radiology devices have obtained FDA clearance. The real-world performance of these technologies may differ when used outside of training and testing environments. Having access to meaningful information could help radiology providers discover appropriate innovations for their clinical needs and estimate software performance when paired with their respective patient populations and subpopulations, image acquisition/input devices and imaging protocols. However, access to such information is relatively limited and unintuitive.
ACR written comments provided input about the type of device data that would be helpful to radiology providers, ideas for usable presentations of device information to stakeholders and a recommendation for an alternative reporting mechanism to openly share software performance issues that do not result in patient harm.
For more information about FDA oversight of AI/ML-enabled radiology devices, please contact Michael Peters, ACR Government Affairs Director.