USA – During pandemic, FDA permits some respiratory swab, media swaps

Amid the coronavirus pandemic, the US Food and Drug Administration (FDA) has made new guidance immediately effective that addresses its enforcement policy for modifications to previously cleared molecular tests for other common respiratory pathogens.

During the public health emergency of the COVID-19 pandemic, FDA does not intend to enforce the requirement for obtaining 510(k) clearance for certain modifications of molecular respiratory pathogen tests, including use of additional transport media and use of different swab types with the tests, provided the modifications do not create undue risk.

The intent of the guidance, said FDA, is to “help expand access to certain FDA-cleared molecular assays intended for detection and identification of influenza (flu) viruses, including those molecular influenza assays that also detect and identify respiratory syncytial viruses (RSV), during the influenza season and for the duration of the COVID-19 public health emergency.”

Molecular assays for viral respiratory pathogens, said the agency, have clinical utility because influenza, RSV and COVID-19 infections have “significant overlap in warning signs and symptoms.” Many of these tests also use the same components, including specimen collection devices and transport media, raising the possibility of supply and distribution problems as the influenza season ramps up and the pandemic shows no sign of waning…