FDA perspectives on diagnostic device clinical studies for respiratory infections

Clinical Infectious Diseases

Volumn 52, Issue SUPPL. 4, 2011, Pages

  Russek Cohen, Estelle ^a   Feldblyum, Tamara ^b   Whitaker, Kathleen B ^b   Hojvat, Sally ^b  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^b CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL EFFECTIVENESS; DEVICE APPROVAL; DEVICE SAFETY; DIAGNOSTIC KIT; EVALUATION RESEARCH; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; MARKETING; MOLECULAR DIAGNOSIS; PREDICTIVE VALUE; PREVALENCE; PRIORITY JOURNAL; PROSPECTIVE STUDY; REPRODUCIBILITY; RESPIRATORY TRACT INFECTION; RETROSPECTIVE STUDY; SENSITIVITY AND SPECIFICITY;

DIAGNOSTIC TEST APPROVAL; HUMANS; MOLECULAR DIAGNOSTIC TECHNIQUES; REAGENT KITS, DIAGNOSTIC; RESPIRATORY TRACT INFECTIONS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79953801416     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/cir056     Document Type: Article

References (12)

1. FDA guidance for industry and FDA staff: statistical guidance on re-porting results from studies evaluating diagnostic tests. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm071287.pdf. Accessed March 2007
2. FDA guidance for industry and FDA staff: class II special controls guidance documents: respiratory virus panel multiplex nucleic acid assay. Available at: http://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm180324.pdf. Accessed October 2009
3. FDA guidance for industry and FDA staff: class II special controls guid-ance document: testing for detection and differentiation of influenza A virus subtypes using multiplex nucleic acid tests. Available at: http://www. fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ ucm180310.pdf. Accessed October 2009
4. FDA draft guidance: establishing performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of influenza viruses. Available at: http://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm071458.pdf. Accessed February 2008.
5. Pepe MS. The statistical evaluation of medical tests for classification and prediction. Oxford: Oxford University Press, 2003; 302.
6. CLSI EP5 2A: establishment of precision of quantitative measure-ment procedures. Wayne, PA: Clinical Laboratory and Standards Institute; 2004.
7. CLSI MM17A: verification and validation of multiplex nucleic acid assays. Wayne, PA: Clinical Laboratory and Standards Institute; 2008.
8. CLSI EP17A: protocols for determination oflimits of detection and limits of quantitation. Wayne, PA: Clinical Laboratory and Standards Institute; 2004.
9. FDA guidance for industry and FDA staff: recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver applica-tions for manufacturers of in vitro diagnostic devices. Available at: http://www.fda.gov/ downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ ucm070890.pdf Accessed January 2008
10. FDA guidance for industry and FDA staff: guidance for the content of premarket submissions for software contained in medical devices, Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm089593.pdfAccessed May 2005.
11. FDA guidance for industry, FDA reviewers and compliance on offtheshelf software use in medical devices. Available at: http://www.fda.gov/downloads/ MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073779.pdf. Accessed September 1999
12. FDA draft guidance for industry and FDA staff: in vitro diagnostic (IVD) device studies\frequently asked questions. Available at: http://www.fda.gov/ MedicalDevices/DeviceRegulationandGuidance/IVDRegulatory Assistance/ucm123682. htm#8. Accessed October 2007.