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They include devices that detect one specific type or subtype, as well as devices that detect more than one type or subtype of influenza virus and further differentiate among them. These devices are used to aid in the diagnosis of influenza infection. IntroductionįDA is issuing this guidance to provide industry and agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) intended for the detection, or detection and differentiation, of influenza viruses. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. 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 Controls for Nucleic Acid-based Influenza Assays.Specimen Storage and Shipping Conditions.Carry-Over and Cross-contamination Studies (for multi-sample assays and devices that require instrumentation.).Establishing Performance Characteristics.Interpreting and Reporting Test Results.Please use the document number 1638 to identify the guidance you are requesting. You may also send an e-mail request to to receive an electronic copy of the guidance or send a fax request to 30 to receive a hard copy. Additional CopiesĪdditional copies are available from the Internet.

Comments may not be acted upon by the Agency until the document is next revised or updated. Identify all comments with the docket number FDA-2008-D-0095. You may submit written comments and suggestions at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. Office of In Vitro Diagnostic Device Evaluation and Safety Department of Health and Human ServicesĬenter for Devices and Radiological Health