Life Sciences

FDA focuses on flu tests

Device Regulation Alert: Safety, Compliance and Reimbursement News, June 11, 2007

To market in vitro diagnostic devices to detect Influenza A (or A/B) viruses need new labels. FDA guidance issued in May addresses the need for clear labeling and instructions on the limitations of these devices, which include CLIA-waived rapid influenza tests. The FDA noted that clarity in labeling is essential due to emerging influenza viruses.

Manufacturers whose in vitro diagnostic devices were cleared before this guidance may need to revise their labeling. The FDA recommends that such manufacturers make revisions to printed labeling by October.

The FDA guidance recommends labeling for these influenza A (or A/B) test devices include the following (which may not all apply to every device):

  • A comment in the statement of intended use on the label and labeling/package inserts indicating that negative test results should be confirmed by cell culture and should not be the "sole basis" for treatment

  • For devices already cleared by the FDA, a caution that "performance characteristics may vary" if there are emerging influenza A viruses that were not found when those characteristics were established.

  • The summary and explanation section of labeling should be carefully worded to avoid leading users to think that device can specifically detect A/H5N1 virus or "differentiate specific novel influenza A viruses."

    Other recommendations address issues such as

  • a statement of precautions regarding human specimens handling and disposal,

  • a warning that improper specimen collection can affect results,

  • discussion of what test results obtained with the device mean,

  • and an explanation of limitations on the test device's ability to distinguish between types of influenza viruses.

    Finally, the guidance recommends that performance characteristics information explain the groups of patients and specimen sources used to establish the characteristics and note the type of influenza observed during the time the characteristics were established.

    The guidance also addresses the premarket process for new influenza detecting devices and when manufacturers should try to demonstrate their new device is substantially equivalent to a predicate device. Device manufacturers already cleared for marketing should submit a new 510(k), the FDA recommends, before they claim the device can detect specific influenza A viruses or novel influenza viruses.

    To view the guidance, click here.

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