The FDA’s focus is thus far on tests and devices rather than the condition.
https://www.optometrytimes.com/view/fda-clears-the-first-early-detection-sepsis-test-in-emergency-department-focused-diagnostic-tools
https://ambientclinical.com/2022/10/31/newly-released-fda-guidelines-sepsis-detection-means-hospitals/#:~:text=With%20this%20guidance%2C%20EHR%20companies,without%20obtaining%20FDA%20clearance%20first.
Cell Therapy News/Articles, page-17564
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