For immediate release:

The United States Food and Drug Administration today announced the following actions taken as part of its ongoing response efforts to the COVID-19 pandemic:

  • On Friday, October 22, 2021, Acting FDA Commissioner Janet Woodcock, MD, and FDA Biologics Assessment and Research Center Director Peter Marks, MD, Ph.D., discussed the Action Taken by the FDA to Expand the Use of a Single Booster Dose for COVID-19 Vaccines in Eligible Populations. Specifically, they covered the use of a single booster dose of the Moderna and Janssen (Johnson and Johnson) COVID-19 vaccines, clarified the use of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for eligible persons and covered the use of each of the COVID-19 vaccines available as a heterologous (or “mix and match”) booster dose in eligible persons. Healthcare professionals, patient advocacy groups, trade associations, consumer organizations, national immunization organizations, and state and local public health organizations have been invited to the call. To listen to the appeal, visit the FDA’s YouTube channel.
  • The FDA is investigating certain imported medical gloves that appear to have been reprocessed, cleaned or recycled and sold as new. The FDA has determined that many foreign manufacturers and shippers of medical gloves have not consistently supplied medical gloves of adequate quality for distribution in the United States. The FDA recommends that healthcare institutions and providers do not purchase or use imported medical gloves from companies included in Import Alert 80-04 Surveillance and Detention Without Physical Examination of Surgeon’s and Patient Examination Gloves and report any issues. with medical gloves.
  • The FDA has cleared the 11th over-the-counter (OTC) COVID-19 test. The FDA is committed to increasing the availability of accurate and reliable COVID-19 home diagnostic tests and to making it easier for consumers to access these tests. The FDA has issued an Emergency Use Clearance (EUA) for the Detect Covid-19 test, an OTC COVID-19 diagnostic molecular test. The test requires the use of a compatible smartphone and a downloadable app to provide test instructions and provides results in about an hour.

    The test can be used as:

    • One test for people with symptoms of COVID-19.
    • A serial test for people without symptoms. A serial test means that the test is performed twice in three days.

    The test can be used for people:

    • Age 14 years or older with a self-collected nasal swab sample.
    • Age 2 years and over when an adult collects the nasal swab sample.
  • Testing updates:
    • To date, 421 tests and specimen collection devices have been approved by the FDA under Emergency Use Authorizations (EUA). These include 293 molecular tests and specimen collection devices, 90 antibody tests and other immune response tests, and 38 antigen tests. There are 66 molecular clearances and one antibody clearance that can be used with home samples. There is one EUA for home molecular prescription testing, three EUAs for home antigen prescription testing, nine EUAs for home over-the-counter (OTC) antigen testing, and three EUAs for OTC molecular testing. home.
    • The FDA has authorized 16 antigen tests and nine molecular tests for serial screening programs. The FDA has also cleared 667 revisions to EUA authorizations.

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The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.