> ## Content Index
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# Draft Guide on Infectious Disease Next Gen Sequencing Diagnostics
- URL: https://www.fdaweb.com/draft-guide-on-infectious-disease-next-gen-sequencing-diagnostics/
- Published: 2016-05-12T12:00:00.000Z
- Updated: 2026-09-14T21:02:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135655

> FDA has issued a [draft guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM500441.pdf?ref=fdaweb.com) on “Infectious Disease Next Generation Sequencing Based Diagnostic Devices:Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers,” which provides recommendations for studies to establish the analytical and clinical performance characteristics of such devices. “Each unique specimen type may require a different nucleic acid extraction procedure, a different library preparation protocol, and even a different bioinformatics algorithm to generate the final clinical result,” the document says. “The opportunity for repeat testing is expected to be limited due to a frequently small specimen quantity, and the necessity to make a prompt and timely infectious disease treatment decision for the patient.”  
>  
> The draft also provides detailed information on the types of data FDA recommends be submitted to support a Class 2 premarket submission. “The inclusion of certain targets (e.g., Hepatitis B, Hepatitis C, HPV and HIV) could elevate the classification of the device to Class 3, and FDA encourages you to contact the agency for additional guidance,” it says.