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# Guidance on Infectious Disease Diagnostics
- URL: https://www.fdaweb.com/guidance-on-infectious-disease-diagnostics/
- Published: 2016-05-13T12:00:00.000Z
- Updated: 2026-09-14T21:02:34.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135670

*Federal Register* Notice: FDA is making available a draft guidance entitled *Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers*. It provides recommendations to assist industry in designing 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. To download this draft guidance, click [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM500441?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-05-13/pdf/2016-11237.pdf?ref=fdaweb.com)