FDA aims to stem AI device bias, boost transparency in draft guidance

FDA aims to stem AI device bias, boost transparency in draft guidance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

by Elise Reuter • 1 month ago

The FDA has issued draft guidance for manufacturers on the design, development, and maintenance of AI-enabled medical devices. This document emphasizes the importance of transparency and bias mitigation, urging manufacturers to provide details about AI usage, datasets, and performance monitoring plans. The FDA has authorized over 1,000 AI devices and seeks public comments on the guidance until April 7, highlighting the need for ongoing evaluation of device performance throughout their lifecycle.

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