The Food and Drug Administration last week reissued its emergency use authorization for the Abbott ID NOW COVID-19 test to indicate that the product is intended for specimens collected “from individuals who are suspected of COVID-19 by their health care provider within the first seven days of the onset of symptoms.” 

The revised EUA also clarifies that the test is authorized for emergency use by laboratories certified under the Clinical Laboratory Improvement Amendments that meet the requirements to perform high, moderate or waived complexity tests; and that U.S. testing facilities must report all results to the appropriate public health authorities.

Related News Articles

Perspective
We’ve been discussing for months how hospitals and health systems are contending with the worst financial crisis in their history as they continue to serve on…
Headline
“The COVID-19 pandemic has proved that crisis tends to be a driver of innovation,” writes Jonathan Bandel, vice president of strategy and innovation for New…
Headline
The Food and Drug Administration Wednesday updated its guidance on enforcement policy for non-invasive remote monitoring devices that support patient…
Headline
The Centers for Medicare & Medicaid Services yesterday announced an interim final rule establishing additional Medicare hospital payment to support…
#HealthCareInnovation Thursday Blog
When the first case of coronavirus was confirmed in New Rochelle, New York, in early March, White Plains Hospital, a 292-bed tertiary care hospital located…
Headline
In partnership with the AHA’s Center for Health Innovation and other national health care organizations, the Centers for Disease Control and Prevention today…