FDA calls on makers of AI devices to disclose more details

The Food and Drug Administration wants developers of medical devices that rely on artificial intelligence to disclose far more details about how their devices were developed and tested, and what needs to be done to guard against safety risks in medical settings.

In a new draft guidelinesThe FDA is calling on AI device makers to describe the sources and demographics of data used to train and validate their products, and to disclose potential blind spots and biases that could harm performance. The information would be included in the agency’s requests for approval.

While the document is advisory in nature and does not impose new rules on device makers, it aims to raise the bar for companies that have so far gained approvals for AI products without fully describing their training, testing, and limitations. It remains to be seen whether its recommendations will be endorsed by the new Trump administration, or what level of cooperation the agency will ultimately get from the industry.