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  5. FDA Roundup: December 13, 2022
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FDA News Release

FDA Roundup: December 13, 2022

For Immediate Release:

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

  • On Monday, the FDA updated the device shortage list to remove medical gloves (product codes LYY, LYZ, LZA and LZC). The FDA will continue to monitor the supply chain and update the device shortage list and device discontinuance list as new information becomes available. The FDA also updated the frequently asked questions about medical gloves during the COVID-19 public health emergency. For more information, see Medical Gloves for COVID-19. For questions about the medical device supply chain and shortages, see Supplies of Medical Devices for COVID-19: Frequently Asked Questions.
  • On Monday, the FDA released Advancing Food Safety Culture as Science Not a Slogan: A Systematic Literature Review, as a foundation for the FDA’s work on food safety culture with industry, consumers and within the agency. The FDA believes that to make dramatic improvements in reducing the burden of foodborne disease we must do more to influence the beliefs, attitudes and the behaviors of people and the actions of organizations. 
  • COVID-19 testing updates: 
    • As of today, 440 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 298 molecular tests and sample collection devices, 86 antibody and other immune response tests, 55 antigen tests and 1 diagnostic breath test. There are 79 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 23 EUAs for antigen over-the-counter (OTC) at-home tests and 4 for molecular OTC at-home tests.
    • The FDA has authorized 39 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1172 revisions to EUA authorizations

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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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