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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| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2025-05-01
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| Series: | npj Digital Medicine |
| Online Access: | https://doi.org/10.1038/s41746-025-01717-9 |
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