Nearly 20% of AI/ML Devices in Study Have Inaccurate Marketing Information

Nearly 20 percent of AI and machine learning (ML) devices in a study had discrepancies between FDA-cleared indications for use and information included in marketing materials, according to a report published Wednesday in JAMA Open Network.

The authors collected data on 119 FDA 510(k) devices cleared between March and November 2022 and “the aim of the study was not to suggest developers were creating and marketing unsafe or untrustworthy devices but to show the need for study on the topic and more uniform guidelines around marketing of software-heavy devices,” the study says.

The study analyzed accompanying marketing materials, sorting the devices into three categories: adherent, contentious or discrepant.

While the study didn’t determine the reasons for the discrepancies, the authors conclude that further qualitative analysis “may shed more light on the subject, but any level of discrepancy is important to note for consumer safety.”

Read the full report here.

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