New Approach for Certain COVID-19 Tests: Adding Pooling Claims

Allows certain authorized tests to be used for pooled serial screening after certain requirements are met, including notification to FDA.

If your email program has trouble displaying this email, view as a webpage. FDA Offers New Approach for COVID-19 Diagnostic Test Developers Seeking Pooled Serial Screening Claims Today, the U.S. Food and Drug Administration (FDA) took steps to further facilitate the authorization of tests for pooling specimens from asymptomatic individuals in serial testing programs. The FDA issued an amendment for many molecular diagnostic COVID-19 tests that had received an emergency use authorization (EUA). Read More This Pooling and Serial Testing amendment: Applies to many molecular diagnostic COVID-19 tests already authorized for testing individual samples. Requires test developers to submit a notification to the FDA with the information required by the amendment, including self-certifying that the applicable validation has been completed.  Further supports the expansion of COVID-19 testing in schools, workplaces, communities, and other entities looking to establish serial testing programs for people without symptoms and with no known suspected exposure to COVID-19. Questions? If you have questions, email COVID19Dx@fda.hhs.gov.

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