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GUIDANCE DOCUMENT

Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers Draft Guidance for Industry and Food and Drug Administration Staff May 2016

Download the Draft Guidance Document
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2016-D-0971
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA is issuing this draft guidance to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance characteristics of Infectious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 (hereafter referred to as “Infectious Disease NGS Dx devices”).

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-0971.

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