In an attempt to increase the availability of tests for the coronavirus, several diagnostic companies are utilising the FDA’s Emergency Use Authorisation (EUA).
The EUA was originally developed to permit access to unapproved medical products, or unapproved uses of approved medical products, when there are no adequate or approved alternatives available during times of emergency.
To date, companies that have received EUA’s from the FDA for Covid-19 tests include:
AdvaMed president and CEO Scott Whitaker commented: “The medical technology industry has always been front and centre during any public health emergency, and it is no different with the coronavirus. Many companies are adding third shifts, working 24/7, and adding new production lines in order to provide patients and healthcare providers what they need to detect, contain and treat this virus.
“It truly is incredible to watch our entire medtech community rally to this global cause. We thank these diagnostics companies for rapidly developing coronavirus tests, and we thank Dr. Hahn and the FDA for working so hard to authorise them quickly.”
“AdvaMedDx member companies are among those on the forefront of the medtech industry’s response to the coronavirus. They are increasing availability of Covid-19 testing while continuing to ensure access to all the diagnostics so fundamental to patients and health care in the U.S. and around the world,” added AdvaMedDx executive director Susan Van Meter.