In certain emergencies, like the current COVID-19 pandemic, the FDA can quickly issue an Emergency Use Authorization for diagnostic tests based on a rolling review of data and when the request meets certain criteria. In the COVID-19 pandemic, the FDA has worked with more than 160 test developers who have said they will be submitting applications to make tests that detect the virus.
To date, 15 emergency use authorizations have been issued for nationwide use. The FDA is doing everything it can to support patients, healthcare professionals, and the public during this pandemic. The Avania team has also been on the front lines, assisting manufacturers of regulated products through the EUA process. Contact us to learn more about what we can do to support your efforts during these challenging times.
The Avania Team