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.
January 28, 2016
On December 31, 2015, FDA released a draft guidance entitled “Public Notification of Emerging Postmarket Medical Device Signals (‘Emerging Signals’),” which stated its plans to take a more aggressive...
February 28, 2019
On Tuesday, February 19th, FDA published a draft guidance for medical device makers which identifies a process for companies to request nonbinding feedback on certain FDA Form 483 deficiencies noted...
November 30, 2018
On Monday, November 26th, FDA announced changes to modernize the 510(k) clearance pathway, which is the most common medical device submission and allows for the allows for the “clearance of low- to...