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FDA News Release

Coronavirus (COVID-19) Update: October 30, 2020

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 Consumer Update, “Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy.” COVID-19 is one of many health issues that may cause oxygen levels to drop. When the levels are too low, consumers may need to take extra oxygen, known as oxygen therapy. One way to get extra oxygen into the body is by using an oxygen concentrator. Oxygen concentrators are medical devices required to be sold and used only with a prescription.

    You should not to use an oxygen concentrator at home unless it has been prescribed by a health care provider. Deciding to use an oxygen concentrator without a prescription can lead to serious health problems such as oxygen toxicity caused by receiving too much oxygen. It can also lead to a delay in receiving treatment for serious diseases like COVID-19.
  • Testing updates:
    • As of today, 287 tests are authorized by FDA under EUAs; these include 223 molecular tests, 57 antibody tests, and 7 antigen tests.

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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