A general framework for governing marketed AI/ML medical devices

Abstract This project represents the first systematic assessment of the US Food and Drug Administration’s postmarket surveillance of legally marketed artificial intelligence and machine learning based medical devices. We focus on the Manufacturer and User Facility Device Experience database—the FDA’...

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Bibliographic Details
Main Authors: Boris Babic, I. Glenn Cohen, Ariel Dora Stern, Yiwen Li, Melissa Ouellet
Format: Article
Language:English
Published: Nature Portfolio 2025-05-01
Series:npj Digital Medicine
Online Access:https://doi.org/10.1038/s41746-025-01717-9
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