Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use; Public Workshop; Request for Comments

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use.'' The purpose of this workshop is to receive input from stakeholders and discuss approaches to the study of non-microbial biomarkers for differentiating viral from bacterial infections and for diagnosis and assessment of sepsis. Comments and suggestions generated through this workshop will facilitate further development of regulatory science for establishing appropriate comparator methods and clinically relevant performance standards for non-microbial based in vitro diagnostics for infection.