Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., June 5, 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 issued an updated FDA COVID-19 Response At-A-Glance Summary that
        provides a quick look at facts, figures and highlights of the agency's
        response efforts.

    --  The FDA is changing the hours for the COVID-19 Industry Hotline
        (1-888-INFO-FDA, press *). To best meet current needs, the Hotline
        operate from 8:00 a.m. to 8:00 p.m. Eastern Time, Monday through Friday.
        For urgent inquiries, the FDA Emergency Line (1-866-300-4374) remains
        available after-hours. The FDA has also published and continues to
        update extensive resources on COVID-19 and medical devices to help
        answer questions.

    --  Effective immediately, new guidance issued by the FDA expands the
        availability and capability of non-invasive monitoring devices. These
        remote devices facilitate patient monitoring while reducing patient and
        healthcare provider contact and exposure to COVID-19 for the duration of
        the COVID-19 public health emergency. This guidance replaces the March
        20, 2020, guidance, titled "Enforcement Policy for Non-Invasive Remote
        Monitoring Devices Used to Support Patient Monitoring During the
        Coronavirus Disease 2019 (COVID-19) Public Health Emergency." The new
        guidance expands the scope to include additional device types (product
        codes) and provides additional references and standards for
        consideration.

    --  Testing updates:
        --  During the COVID-19 pandemic, the FDA has worked with more than 400
            test developers who have already submitted, or said they will be
            submitting, EUA requests to the FDA for tests that detect the virus
            or antibodies to the virus.
        --  To date, the FDA has authorized 124 tests under EUAs, which include
            106 molecular tests, 17 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: Lee.Herring@fda.hhs.gov, 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