Lexology November 21, 2021
The Food and Drug Administration recently sought comments on the role of transparency for artificial intelligence and machine learning-enabled medical devices. The FDA invited comments in follow up to a recent workshop on the topic.
The workshop was part of a series of efforts the FDA has had in this space. These include its Digital Health Center of Excellence and a five-part Action Plan for AI and machine-learning enabled medical devices. As part of the action plan, the FDA indicated it wants to issue guidance on software learning over time and help the industry be “patient-centered.” In other words, that companies be transparent when using AI and machine learning-enabled software with patients. These initiatives are especially important given the increase...