sábado, 14 de mayo de 2016

CDRH Industry: Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers - Draft Guidance for Industry and FDA Staff

The U.S. Food and Drug Administration has posted a draft guidance titled, “Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers. FDA is issuing this draft guidance to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance characteristics of Infectious Disease Next Generation Sequencing Based Diagnostic Devices for Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers. These devices are for use as aids in the diagnosis (identification) of microbial infection and in selecting appropriate therapies.

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