United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
2014_register
executive
2014-10-07
article
Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Notices
D09002ee1bdc3ce2c
D09002ee1bdc3cea7
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices.'' This guidance is to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of highly multiplexed microbiological/medical countermeasure in vitro nucleic acid-based diagnostic devices (HMMDs) intended to simultaneously detect and identify multiple pathogen nucleic acids extracted from a single appropriate human specimen or culture.
79 FR 51182
https://www.govinfo.gov/app/details/FR-2014-08-27/2014-20291
2014-20291
fr27au14-71
4164-01-P
Docket No. FDA-2014-N-1082
https://www.govinfo.gov/app/details/FR-2014-08-27/2014-20291
https://www.govinfo.gov/content/pkg/FR-2014-08-27/html/2014-20291.htm
https://www.govinfo.gov/content/pkg/FR-2014-08-27/pdf/2014-20291.pdf
2 p.
51182
51183
79 FR 51182
Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 79, Issue
NOTICE
2014-20291
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2014-N-1082
4164-01-P
2014-20291
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices.'' This guidance is to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of highly multiplexed microbiological/medical countermeasure in vitro nucleic acid-based diagnostic devices (HMMDs) intended to simultaneously detect and identify multiple pathogen nucleic acids extracted from a single appropriate human specimen or culture.
Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
John Hobson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5560, Silver Spring, MD 20993-0002, 301-796-5892.
Guidance:
Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices
,
CDRH-Guidance@fda.hhs.gov
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
http://www.regulations.gov
Federal Register
Vol. 79, no. 166
Office of the Federal Register, National Archives and Records Administration
2014-08-27
continuing
daily
deposited
born digital
173 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2014-08-27
P0b002ee189da4b55
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr27au14
https://www.govinfo.gov/app/details/FR-2014-08-27
https://www.govinfo.gov/content/pkg/FR-2014-08-27/pdf/FR-2014-08-27.pdf
https://www.govinfo.gov/content/pkg/FR-2014-08-27/xml/FR-2014-08-27.xml
fdlp
51067
51228
DGPO
2014-10-07
2023-04-29
FR-2014-08-27
machine generated
eng
FR
FR-2014-08-27
79
166