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FDA.gov

Collected by: U.S Food and Drug Administration

Archived since: Oct, 2016

Description:

Snapshot of the www.FDA.gov website

Subject:   Science & Health,  Government - US Federal

Creator:   FDA Office of the Commissioner, Office of External Affairs

Date:   October 21 2016

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Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses | FDA

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-performance-characteristics-vitro-diagnostic-devices-detection-or-detection-and-0

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Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses Regulatory Information GUIDANCE DOCUMENT Establishing the Performance Characteristics

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Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses | FDA

URL: https://www.fda.gov/node/381761

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Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses | FDA Skip to main content Skip to FDA Search Skip

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Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff | FDA

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-performance-characteristics-vitro-diagnostic-devices-detection-antibodies-borrelia

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Establishing Performance Characteristics A.

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Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff

URL: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm345170.htm

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Establishing Performance Characteristics A.

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Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff | FDA

URL: https://www.fda.gov/node/363360

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Establishing Performance Characteristics A.

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Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of methicillin-resistant Staphylococcus aureus (MRSA) for Culture Based Devices

URL: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm259076.htm

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Establishing Performance Characteristics for Culture Methods A.

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Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff | FDA

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-performance-characteristics-vitro-diagnostic-devices-detection-or-detection-and

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Establishing Performance Characteristics 9.A Analytical Performance We recommend that you establish the following analytical performance characteristics for your assay: 9.A.i Analytical Sensitivity Limit

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Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff | FDA

URL: https://www.fda.gov/node/355865

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Establishing Performance Characteristics 9.A Analytical Performance We recommend that you establish the following analytical performance characteristics for your assay: 9.A.i Analytical Sensitivity Limit

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Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses

URL: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079171.htm

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Establishing Performance Characteristics 9.A Analytical Performance We recommend that you establish the following analytical performance characteristics for your assay: 9.A.i Analytical Sensitivity Limit

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Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for Chlamydia trachomatis and/or Neisseria gonorrhoea: Screening and Diagnostic Testing

URL: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm254813.htm

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Establishing Performance Characteristics A.

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Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori

URL: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm226966.htm

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Establishing Performance Characteristics We recommend that you provide a copy of your study protocols.

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CBER's policies on assay regulation: Definitions of assay performance characteristics

URL: https://www.fda.gov/ohrms/dockets/ac/99/slides/3541s1d/index.htm

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CBER's policies on assay regulation: Definitions of assay performance characteristics CBER's policies on assay regulation: Definitions of assay performance characteristics 7/25/00 Click here to start Table

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https://www.fda.gov/ohrms/dockets/ac/99/slides/3541s1.htm

URL: https://www.fda.gov/ohrms/dockets/ac/99/slides/3541s1.htm

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ANTIVIRAL DRUGS ADVISORY COMMITTEE November 2, 1999 Slides HIV-1 Resistance Testing in Drug Development, Heidi Jolson, MD ppt htm SESSION 1-Performance Characteristics and Limitations of Currently Available

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Slide 1

URL: https://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4409s1-02-FDA-Becker_files/slide0023.htm

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Test performance depends partly on recognizing what analytical performance characteristics are needed , and designing the test to meet these needs.

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Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses

URL: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm181509.htm

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Establishing Performance Characteristics A.

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Information for Industry: X-ray Imaging Devices

URL: https://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/MedicalX-Rays/ucm265966.htm

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CT: Specifies that CT scanners provide an AEC feature, but does not specify any test of AEC performance .

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Information for Industry: X-ray Imaging Devices | FDA

URL: https://www.fda.gov/radiation-emitting-products/medical-x-ray-imaging/information-industry-x-ray-imaging-devices

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CT: Specifies that CT scanners provide an AEC feature, but does not specify any test of AEC performance .

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Information for Industry: X-ray Imaging Devices | FDA

URL: https://www.fda.gov/node/362046

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CT: Specifies that CT scanners provide an AEC feature, but does not specify any test of AEC performance .

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FDA continues to take steps to fulfill its commitment to strengthen and modernize the 510(k) medical device program | FDA

URL: https://www.fda.gov/news-events/press-announcements/fda-continues-take-steps-fulfill-its-commitment-strengthen-and-modernize-510k-medical-device-program

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characteristics of modern predicates.

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-Session 1- Performance Characteristics and Limitations of Currently Available Genotypic and Phenotypic Assays

URL: https://www.fda.gov/ohrms/dockets/ac/99/slides/3541s1b/index.htm

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-Session 1- Performance Characteristics and Limitations of Currently Available Genotypic and Phenotypic Assays -Session 1- Performance Characteristics and Limitations of Currently Available Genotypic and

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