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October 28, 2021 Agency Alerts

FDA Revokes Emergency Use Authorization of IVD Device for COVID-19 Detection


On Wednesday, October 27th, FDA revoked Life Technologies Corporation’s Emergency Use Authorization (EUA) for its TaqPath COVID-19 MS2 Combo Kit 2.0.

Background

On August 2, 2021, FDA issued an EUA to Life Technologies Corporation (a part of Thermo Fisher) for the TaqPath COVID-19 MS2 Combo Kit 2.0. The product is an in vitro diagnostic device indicated for the detection and/or diagnosis of COVID-19 and was authorized as the Delta Variant wreaked havoc in the US and abroad.

At the same time, Thermo Fisher also obtained authorization for its TaqPath COVID-19 RNase P Combo Kit 2.0 assay. The two products were “designed with increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants.”

FDA Revokes EUA

On September 17, 2021, FDA revoked the Thermo Fisher’s EUA for its TaqPath COVID-19 MS2 Combo Kit 2.0. The revocation came after a request was submitted by Thermo Fisher asking FDA for the revocation because “it is no longer commercially supporting the TaqPath COVID-19 MS2 Combo Kit 2.0.” As such, FDA determined that in order to protect the public health and safety, revocation of the in vitro diagnostic (IVD) device was appropriate.

Are you in the process of developing an in vitro diagnostic device? We can help ensure your product meets all regulatory requirements. Contact us today to learn more about our unique set of global regulatory capabilities, including how we can help you achieve successful interactions with regulators across the globe.


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