The U.S. Food and Drug Administration (FDA) is seeking comments on methods of assessing the real-world performance of AI-enabled medical devices, including generative AI. Prior FDA draft guidance has ...
Kimberlee Leonard has 22 years of experience as a freelance writer. Her work has been featured on US News and World Report, Business.com and Fit Small Business. She brings practical experience as a ...
On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The ...
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