Zdrowie i gospodarka · 11.08.2016
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Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for the document entitled "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Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff," that appeared in the Federal Register of May 13, 2016. In the document, FDA requested comments on FDA's 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. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.