FDA: EUAs for COVID-19 Lab Tests Will Continue after PHE Ends
Agency says it will continue to have authority to clear new lab tests and other COVID-19 products on an emergency basis even after the PHE ends.
Diagnostic Testing and Emerging Technologies
LAB COMPLIANCE ADVISOR
LABORATORY INDUSTRY REPORT
NATIONAL LAB REPORTER
Agency says it will continue to have authority to clear new lab tests and other COVID-19 products on an emergency basis even after the PHE ends.
In a move to expand access to lab testing for monkeypox, HHS has authorized the FDA to issue EUAs for in vitro diagnostic tests for the virus.
Counterfeit COVID-19 tests are being illegally imported into the US and being distributed to unsuspecting consumers across the country.
The US Food and Drug Administration recently issued a letter warning people not to use two different tests produced by Empowered Diagnostics.