Public Meeting

These diagnostic devices present several advantages, such as identifying potential disease etiology in situations where many different pathogens share a common clinical manifestation and the simultaneous detection of co -infections. However, establishing and validating the performance of these devices to make informed clinical and public health decisions pose significant scientific challenges.

The purpose of the public meeting is to discuss performance evaluation of highly multiplexed microbiology/medical countermeasure (MCM) devices, their clinical application and public health/clinical needs, and quality criteria for establishing the accuracy of reference databases . These considerations are essential to establish the safety and effectiveness of highly multiplexed devices when used for the clinical diagnosis of infectious diseases from a human specimen.

FDA is holding this public meeting to obtain input from academia, government, industry, clinical laboratories, and other stakeholders on the performance evaluation approach to be proposed by FDA, which includes validation methods, reference panels, and bioinformatic concepts needed to address the clinical and analytical performance requirements for highly multiplexed microbiology/MCM devices. The ultimate goal is to advance regulatory science for highly multiplexed devices used in pathogen detection in order to ensure their safety and effectiveness and thereby provide potential clinical and public health benefits.