Guidance for Reagents for Detection of Specific Novel Influenza A Viruses

OMB clearance is being sought for an information collection that has been established as a special control for the class II device type, Novel Influenza A Reagents. This classification results from the review of a request from a device sponsor (CDC) for a diagnostic test intended to diagnose influenza subtype H5 (Asian lineage), commonly known as avian flu. This classification permits the legal distribution of this device, and the information collection addressed here plays a significant role in providing a reasonable assurance of the safety and effectiveness of this device and of similar future devices. Specifically, the information collection asks sponsors to obtain and analyze data postmarket to ensure the continued reliability of the device, given the propensity of influenza viruses to mutate and the potential for changes in disease prevalence. This involves collecting data on the clinical performance of the device under new prevalence conditions if there is a change in prevalence of influenza caused by the specific novel virus that the device is intended to detect, as compared to the prevalence of this virus when the clinical studies described in the 510(k) were conducted. The information collection described above is a measure that FDA determined to be necessary to provide reasonable assurance of safety and effectiveness of Novel Influenza A Reagents.

The latest form for Guidance for Reagents for Detection of Specific Novel Influenza A Viruses expires 2022-08-31 and can be found here.