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FDA News Release

Coronavirus (COVID-19) Update: February 9, 2021

For Immediate Release:

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • Today, the FDA issued a Letter to Health Care Providers on Using Ventilator Splitters During the COVID-19 Pandemic to provide up-to-date information concerning multiplexing ventilator tubing connectors, also known as ventilator splitters, in situations in which no alternatives for invasive ventilatory support are available. The Letter to Health Care Providers also includes important information about ventilator splitters, including descriptions of features that may reduce certain risks associated with the use of ventilator splitters, considerations for health care providers and facilities when using ventilator splitters, and instructions for reporting problems with a device to the FDA.
  • Testing updates:
    • As of today, 323 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 240 molecular tests and sample collection devices, 69 antibody tests and 14 antigen tests. There are 35 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test and one over-the-counter (OTC) at-home antigen test.

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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