On Wednesday, October 27th, FDA revoked Life Technologies Corporation’s Emergency Use Authorization (EUA) for its TaqPath COVID-19 MS2 Combo Kit 2.0.
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.”
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.
October 28, 2021
Compensating Controls: “A safeguard or countermeasure, external to the device, employed by a user in lieu of, or in the absence of sufficient controls that were designed in by a device manufacturer,...
October 28, 2021
Recently, FDA published a guidance (entitled “Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products”) providing sponsors with recommendations on how...
October 28, 2021
FDA released proposed regulation that would allow sponsors to determine if their product is a drug/device, or if it is not a drug/device. Last week, the Agency announced a proposed rule “to provide...