FDA aims to stem AI device bias, boost transparency in draft guidance

FDA aims to stem AI device bias, boost transparency in draft guidance
healthcaredive.com

by Elise Reuter • 23 days ago

The FDA has issued draft guidance for manufacturers of AI-enabled medical devices, emphasizing the need for transparency and addressing bias in design and maintenance. The recommendations include detailed explanations of AI usage, data sources, and performance monitoring throughout a device's lifecycle. The guidance also encourages the use of predetermined change control plans to enhance device models post-authorization. The public can comment on the draft until April 7, with a webinar scheduled for February 18.

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