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

On Wednesday, October 27^th, 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.

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