During pandemic, FDA permits some respiratory swab, media swaps

Regulatory NewsRegulatory News | 14 October 2020 |  By 

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.
The modifications to which FDA does not intend to object during the public health emergency of the pandemic include adding sterile phosphate buffered saline and sterile normal saline to influenza or RSV tests that were previously indicated for viral transport media.
Also, FDA will not object if FDA-cleared molecular influenza and RSV tests that had been cleared for use with nasopharyngeal swabs are now used with anterior nares or mid-turbinate swabs, if the specimens are collected by a health care provider.
However, the guidance does specify the modifications that FDA believes may pose undue risk. These include adding an additional sample type other than those specified in the guidance; adding use with self-collected specimens as an indication; adding transport media not specified in the guidance; and adding an over-the-counter use or use in a new patient population to indications for FDA-cleared influenza and RSV tests.
Labeling requirements for molecular influenza and RSV types that will be modified should include instructions for collection via alternative collection devices, as well as instructions for handling, storage and transport of any samples collected by the alternative devices.
Labels should be clear about which devices are compatible with which specimen types and collection media. Also, labeling should reflect testing results and specific performance criteria for the alternative collection devices or transport media.
Finally, manufacturers should clearly delineate which indications are FDA-cleared from those that are not. “FDA recommends the labeling include a clear statement that the test has not been reviewed by FDA” for use with the new specimen collection device or transport media, according to the guidance.
Any modifications to FDA-cleared molecular influenza and RSV tests should undergo appropriate validation before distribution, with any changes documented in the device master record and change control records.
Although the guidance was put into effect immediately, industry and members of the public may still submit comments regarding the guidance to FDA.


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Tags: coronavirus, FDA, US

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