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FDA Drafts Guidance on Tests for Flu Viruses

Device Regulation Alert: Safety, Compliance and Reimbursement News, February 25, 2008

Device manufacturers now have more direction on how to gauge the performance of in vitro diagnostic devices used to diagnose influenza viruses, thanks to draft guidance issued by the FDA. The draft guidance applies to devices that identify one type of flu virus and those that can identify and distinguish between multiple types.

The guidance recommends performing studies to address performance characteristics of such devices. It applies to rapid tests and nucleic acid-based test devices. It does not apply to tests for "serological response from the host to the viral antigen." The guidance recommends performing studies for such devices to:

• Test for the device's limits of detection
• Study cross-reactivity to non-influenza micro-organisms
• Evaluate potential interfering substances
• Study all specimens to be mentioned in the device's labeling

The FDA notes this draft guidance supplements prior guidances issued concerning in vitro diagnostic devices for influenza viruses and recommends industry use all the guidance documents when proposing new devices.

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