USA – Industry, clinician groups have different wish lists for AI/ML-enabled device labels

Medical device industry groups are urging the U.S. Food and Drug Administration (FDA) not to rush to create new regulatory requirements around the labeling of medical devices that incorporate artificial intelligence or machine learning (AI/ML), while clinician groups are seeking greater transparency about device algorithms and training data sets.

In total, 15 groups offered comments following a virtual public workshop held by FDA on the transparency of AI/ML-enabled medical devices held in mid-October. The meeting focused on ways to provide transparency through labeling and other public-facing information, including the possibility of a label styled after the nutrition facts on food labels for these medical devices…