In Vitro Diagnostics EUAs | FDA

In Vitro Diagnostics EUAs | FDA

The FDA Updates Templates for Serology Test EUA Requests

Today, the U.S. Food and Drug Administration (FDA) updated the templates for laboratories and commercial manufacturers to help facilitate submission of Emergency Use Authorization (EUA) requests for serology tests.  The updates clarify FDA’s previous recommendations for demonstrating clinical performance and presenting validation data, and provide new recommendations for validation of point-of-care tests.

View Templates Questions? If you have questions, email COVID19Dx@fda.hhs.gov.