Abstract: Current microbiology device review regulatory pathways: practical considerations, 2 1.2.1 Premarket notification 510(k), 2 1.2.2De novo petitions, 3 1.2.3 Premarket application, 4 1.2.4Major elements of an IVD submission to the FDA, 5 1.3 Assay performance characteristics: "Statistics 101" for diagnostic device developers, 7 1.3.1 Sensitivity/specificity, 7 1.3.2Prevalence, negative predictive values, and positive predictive values, 7 1.4 Common issues with new FDA submissions, 8 1.4.1 IVD labeling, 9 1.4.2New technologies, 9 1.4.3How have FDA regulations and policies fostered preparedness for new and emerging pathogens and other public health emergencies?, 9 References,