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U.S. Food and Drug Administration
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Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles | FDA
https://www.fda.gov/medical-devices/software-medical-device-samd/transparency-machine-learning-enabled-medical-devices-guiding-principles
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For a MLMDs, effective transparency ensures that information that could impact patient risks and outcomes is communicated to all interacting with the device.
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