- 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:
- On June 10, the FDA issued a safety communication warning the public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health. In addition, the test labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests. Finally, the test has not been authorized, cleared or approved by the FDA for commercial distribution or use in the United States, as required by law.
- On June 10, 2021, the FDA added sodium citrate tubes used in blood specimen collection (product codes GIM and JKA) to the testing supplies and equipment–specimen collection category on the device shortage list. The device shortage list reflects the categories of devices the FDA has determined to be in shortage at this time, and the FDA will continue to update the lists as the COVID-19 public health emergency evolves. To mitigate ongoing shortages, the FDA is providing sodium citrate blood specimen collection tube conservation strategies.
- Testing updates:
- As of today, 384 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 275 molecular tests and sample collection devices, 81 antibody and other immune response tests and 28 antigen tests. There are 52 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, five antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
- The FDA has authorized 11 antigen tests and three molecular tests for serial screening programs. The FDA has also authorized 532 revisions to EUA authorizations.
Related Information
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Boilerplate
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.
