WebSep 30, 2024 · FDA’s example 33 in the guidance (a software function that analyzes patient-specific medical information to provide a list of follow-up options for the HCP to consider) does not satisfy criterion 4 primarily because “input medical information is not adequately disclosed . . . from the patient’s medical record or . . . the radiologist ...
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FDA Issues Long-Awaited Final Clinical Decision Support Software ...
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