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As Flu Season Approaches, FDA Provides Clinical Laboratories Flexibility to Modify Influenza and RSV Tests

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New FDA memo allows modifications to influenza and RSV testing as way to conserve testing supplies during public health emergency

Due to the increased strain on testing supplies created by the COVID-19 pandemic, the US Food and Drug Administration (FDA) has released enforcement modifications for influenza and respiratory syncytial viruses (RSV) testing to allow greater conservation of testing supplies.

The following is stated in a recent FDA memo: “For the duration of the public health emergency, FDA does not intend to object to the following modifications to certain FDA-cleared molecular influenza and RSV tests without prior submission of a 510(k) premarket notification that do not create an undue risk in light of the public health emergency.”

As part of this announcement, the FDA provides two examples of modification that will be permitted:

  1. “Modifications are made to the FDA-cleared indications, labeling, or materials of an FDA- cleared molecular influenza and RSV test in order to add sterile phosphate buffered saline (PBS) (including molecular grade PBS and other similar formulations such as Dulbecco’s PBS), and sterile normal saline as additional transport media types when the device was previously indicated for VTM.”
  2. “Modifications are made to the FDA-cleared indications, labeling, or materials, of an FDA- cleared molecular influenza and RSV test cleared for use with nasopharyngeal swabs only to add use with healthcare provider collected anterior nares specimens and/or mid-turbinate specimens.”

The FDA also provides examples of modifications deemed not acceptable, including:

  • “Adding a sample type not identified above to an FDA-cleared molecular influenza and RSV test.”
  • “Adding an indication for use with self-collected specimens to an FDA-cleared molecular influenza and RSV test.”
  • “Adding a transport media not identified above to an FDA-cleared molecular influenza and RSV test.”
  • “Adding an over-the-counter (OTC) use or new patient population (e.g., pediatrics) to the indication for an FDA-cleared molecular influenza and RSV test.”

Clinical laboratory leaders interested in implementing changes permitted by the FDA should review the memo here.

Related Resources:

FDA: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency


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