Stakeholders Grapple With Curbing Bias In AI-Based Medical Devices

FDA and medical device developers are grappling with how to eliminate bias in artificial intelligence and machine learning technologies, but there’s a lack of consensus on how to combat bias and ensure AI-enabled devices can be used across populations. Some stakeholders say FDA should use its current authorities to implement labeling requirements for AI devices and incorporate subpopulation analysis into its decision-making process, while industry representatives say the agency should focus on providing incentives, rather than creating new requirements, for...