We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
Abbott Diagnostics

Download Mobile App

ACLA Opposes US FDA’s Decision to No Longer Review EUA Requests for COVID-19 Lab Developed Tests

By LabMedica International staff writers
Posted on 09 Oct 2020
Print article
The US Food and Drug Administration (FDA Silver Spring, MD, USA) will no longer review emergency use authorization (EUA) requests for COVID-19 lab developed tests (LDTs).

The FDA’s decision follows an announcement in August by the US Department of Health and Human Services that LDTs would not be required to undergo premarket review. The FDA has updated its Frequently Asked Questions on the development and performance of diagnostics for SARS-CoV-2, which includes the agency’s plan to decline to review EUA requests for LDTs. However, the FDA will continue to prioritize review of EUA requests for point-of-care tests, home collection tests, at-home tests and any tests that reduce dependence on testing supplies, as well as high-throughput, widely distributed tests. With this shift, the FDA aims to increase testing accessibility and capacity, according to the agency’s updated FAQs.

“We are currently in a different phase of the pandemic with respect to tests than we were previously, where many COVID-19 tests are now authorized to be run in labs,” the FDA wrote. “We prioritize review of EUA requests for tests taking into account a variety of factors, including those discussed in the Emergency Use Authorization of Medical Products and Related Authorities Guidance, such as the public health need for the product and the availability of the product.”

However, the American Clinical Laboratory Association (ACLA Washington, DC, USA) has opposed the FDA’s decision to no longer review EUAs for lab-developed COVID-19 testing. A statement released by the ACLA President Julie Khani said, “Many of the tests that have been granted EUAs for COVID-19 testing are innovative, high-throughput LDTs that have reduced reliance on supplies and been integral to expanding testing capacity. These are exactly the kinds of tests that FDA has stated it wants to prioritize. ACLA believes the FDA should continue to allow labs to voluntarily submit EUAs for FDA review and authorization. Today’s announcement by the FDA creates unnecessary confusion.”

Related Links:
US Food and Drug Administration (FDA)
American Clinical Laboratory Association (ACLA)

Print article
BIOHIT  Healthcare OY


Molecular Diagnostics

view channel
Image: Schematic view of the placenta (Photo courtesy of Wikimedia Commons)

Analysis of Placental Cell Free DNA and RNA Predicts Gestational Complications

A recent paper revealed that circulating cell-free nucleic acids (DNA and RNA) shed from the placenta into the mother's blood during the first trimester of pregnancy could be used to predict potentially... Read more

Industry News

view channel
Image: Mindray Hematology Solution Helps High-Volume Lab Run 2,820,000 CBC Tests Annually (Photo courtesy of Mindray)

Mindray Hematology Solution Helps High-Volume Lab Run 2,820,000 CBC Tests Annually

High-volume laboratories face several challenges, including high instrument failure rate, errors due to several manual steps, low efficiency and long TAT, and heavier workload for the lab staff.... Read more
Copyright © 2000-2020 Globetech Media. All rights reserved.