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Microbial test guidance

This article was originally published in The Gray Sheet

Executive Summary

FDA 1draft guidance released Dec. 8 advises on important technical premarket review issues for genetic assays designed to detect the presence or absence of microbial pathogens. The document, which includes sections on appropriate labeling as well as on assessing analytical and clinical performance of such products, is meant as a general guideline for nucleic acid microbial assays, which can either require 510(k) clearance or PMA approval...
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