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2014-05-30
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Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens
Rules and Regulations
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United States
Department of Health and Human Services
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United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is reclassifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the special controls guideline entitled ``Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens.'' These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.
79 FR 31023
https://www.govinfo.gov/app/details/FR-2014-05-30/2014-12544
2014-12544
fr30my14-3
4160-01-P
Docket No. FDA-2013-N-0544
https://www.govinfo.gov/app/details/FR-2014-05-30/2014-12544
https://www.govinfo.gov/content/pkg/FR-2014-05-30/html/2014-12544.htm
https://www.govinfo.gov/content/pkg/FR-2014-05-30/pdf/2014-12544.pdf
Biologics
Laboratories
Medical Devices
6 p.
31023
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79 FR 31023
Code of Federal Regulations
Title 21 Part 866
21 CFR Part 866
Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens; Federal Register Vol. 79, Issue
RULE
2014-12544
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2014-06-30
Docket No. FDA-2013-N-0544
4160-01-P
2014-12544
Final rule.
The Food and Drug Administration (FDA) is reclassifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the special controls guideline entitled ``Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens.'' These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.
This rule is effective June 30, 2014.
Janice A. Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5554, Silver Spring, MD 20993-0002, 301-796-6207.
Biologics
Laboratories
Medical Devices
Microbiology Devices:
Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens; Reclassification
,
dsmica@fda.hhs.gov
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5801a3.htm
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MicrobiologyDevicesPanel/UCM269469.pdf
http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/UpcomingEventsonCPI/UCM289182.doc
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
http://www.regulations.gov
Federal Register
Vol. 79, no. 104
Office of the Federal Register, National Archives and Records Administration
2014-05-30
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2014-05-30
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https://www.govinfo.gov/app/details/FR-2014-05-30
https://www.govinfo.gov/content/pkg/FR-2014-05-30/pdf/FR-2014-05-30.pdf
https://www.govinfo.gov/content/pkg/FR-2014-05-30/xml/FR-2014-05-30.xml
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