Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development

Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs’ offering independent valuation of models should be available by year-end as part of FDA’s involvement with Coalition for Health AI.

Identifying and fighting bias in artificial intelligence will be one of many priorities for the US Food and Drug Administration going forward as it enhances its regulatory capacity for the technology.

The FDA’s drug, biologic, and device centers, as well as its Office of Combination Products, will collaborate to ensure regulatory...