Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., June 16, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

    --  The FDA posted a new web page, Adverse Event Reporting for Medical
        Devices Under Emergency Use Authorization (EUA) or Discussed in
        COVID-19-Related Guidance Documents. This page answers questions about
        adverse event reporting for medical devices distributed under Emergency
        Use Authorizations (EUAs) or that are the subject of COVID-19-related
        guidance documents and points out a number of adverse event
        reporting-related resources.

    --  The FDA revoked the emergency use authorization (EUA) of the Chembio
        Diagnostic System, Inc.'s, DPP COVID-19 IgM/IgG System, a SARS-CoV-2
        antibody test, due to performance concerns with the accuracy of the
        test. Antibody tests, a type of serological test, can help provide
        information on a person's and population's exposure to COVID-19.

    --  The FDA took a meaningful step forward in getting more tests to more
        Americans more quickly and making that process even easier for
        developers. This was achieved by posting template updates regarding the
        validation of molecular diagnostic tests for developers that intend
        their assay to be used for pooling patient samples or for screening
        asymptomatic individuals not suspected of having COVID-19.
    --  Testing updates:
        --  To date, the FDA has authorized 140 tests under EUAs, which include
            118 molecular tests, 21 antibody tests, and 1 antigen test.

Additional Resources:

    --  FAQs on Testing for SARS-CoV-2
    --  Policy for Coronavirus Disease-2019 Tests During the Public Health
        Emergency (Revised)
    --  Coronavirus Disease 2019 (COVID-19)

Media Contact:, 240-402-6386
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration