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2018-02-09
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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Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period
Notices
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United States
Department of Health and Human Services
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United States Government Agency or Subagency
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Food and Drug Administration
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United States Government Agency or Subagency
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Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff,'' that appeared in the Federal Register of May 13, 2016.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.
81 FR 53149
https://www.govinfo.gov/app/details/FR-2016-08-11/2016-19109
2016-19109
fr11au16-72
4164-01-P
Docket No. FDA-2016-D-0971
https://www.govinfo.gov/app/details/FR-2016-08-11/2016-19109
https://www.govinfo.gov/content/pkg/FR-2016-08-11/html/2016-19109.htm
https://www.govinfo.gov/content/pkg/FR-2016-08-11/pdf/2016-19109.pdf
2 p.
53149
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81 FR 53149
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Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period; Federal Register Vol. 81, Issue
NOTICE
2016-19109
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2016-05-13
Docket No. FDA-2016-D-0971
4164-01-P
2016-19109
Notice; 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.
FDA is extending the comment period on the document published May 13, 2016 (81 FR 29869). Submit either electronic or written comments by September 12, 2016.
Heike Sichtig, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4526, Silver Spring, MD 20993-0002, Heike.Sichtig@fda.hhs.gov.
Guidance for Industry:
Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers
,
Heike.Sichtig@fda.hhs.gov
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.regulations.gov
Federal Register
Vol. 81, no. 155
Office of the Federal Register, National Archives and Records Administration
2016-08-11
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284 p.
Table of Contents:
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AE 2.106:
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https://www.govinfo.gov/app/details/FR-2016-08-11
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https://www.govinfo.gov/app/details/FR-2016-08-11
https://www.govinfo.gov/content/pkg/FR-2016-08-11/pdf/FR-2016-08-11.pdf
https://www.govinfo.gov/content/pkg/FR-2016-08-11/xml/FR-2016-08-11.xml
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2018-02-09
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FR-2016-08-11
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