July 27, 2021 — Following the CDC announcement that FDA emergency use authorization (EUA) for its COVID-19 PCR test will be withdrawn at the end of 2021, GlobalData, a data and analytics company, offers an analyst's view from Dara Lo, Medical Devices Analyst at GlobalData.
“This planned withdrawal could mark a bellwether of EUA approved COVID-19 tests coming to an end. This would have a huge impact on the entire COVID-19 testing industry in the U.S., which is currently comprised almost entirely of COVID-19 tests with only FDA EUA approval. In contrast to fully FDA approved medical tests, EUAs are only given during a declared emergency; outside of this, an EUA cannot be given and cannot be used.
“With the significant decline in COVID-19 testing in the US reported in the first half of the year, and the wide availability of COVID-19 vaccines, this state of emergency cannot last forever. Yet, COVID-19 testing will remain paramount in the monitoring of the prevalence of COVID-19, as well as vaccine efficacy. So even when the pandemic passes, COVID-19 tests will still be needed, similar to how influenza testing is regularly used.
“If and when FDA EUA comes to an end, manufacturers of COVID-19 tests will need to seek regular FDA approval, which can require even more clinical evidence than what was required for an EUA.”
For more information: www.globaldata.com
For the latest information on COVID-19 and the medical imaging industry, see ITN's COVID-19 channel.
Related Radiology COVID-19 Content:
Medical AI Models Rely on 'Shortcuts' That Could Lead to Misdiagnosis of COVID-19
CT Provides Best Diagnosis for Novel Coronavirus (COVID-19)
SNMMI Image of the Year: PET Imaging Measures Cognitive Impairment in COVID-19 Patients
Cardiac MRI Effective in Detecting Asymptomatic, Symptomatic Myocarditis in Athletes
PHOTO GALLERY: How COVID-19 Appears on Medical Imaging
VIDEO: How to Image COVID-19 and Radiological Presentations of the Virus — Interview with Margarita Revzin, M.D.
How Does COVID-19 Appear in the Lungs?
Find more radiology related COVID news and video
PHOTO GALLERY: How COVID-19 Appears on Medical Imaging
April 15, 2026 
