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Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On March 18, the FDA added the following frequently asked questions to the COVID-19 Test FAQs:
- Are at-home COVID-19 tests safe to use? Do they contain toxic chemicals?
- Can I use an FDA authorized at-home COVID-19 diagnostic test that is expired?
- On March 18, the FDA issued a safety communication to alert people of the potential for harm if FDA-authorized at-home COVID-19 tests are not used according to the manufacturer’s test instructions. The FDA is also reminding people to keep the tests out of reach from children and pets. The FDA has received reports of injuries caused by the incorrect use of at-home COVID-19 tests, such as people putting the test chemicals in their eyes, due to the small vials of test solution were mistaken for eye drops. The FDA is also aware of children putting small plastic vials in their mouth and swallowing test solution. This safety communication provides:
- Recommendations for people using FDA-authorized at-home COVID-19 diagnostic tests
- Background on the issue and the FDA’s actions
- Instructions for reporting problems with at-home COVID-19 testing to the FDA
- On March 16, the FDA published the Medical Countermeasures Initiative (MCMi) Program Update report showcasing the FDA's work each year in order to prepare for various public health emergencies, including COVID-19. This report, covering fiscal year 2021, includes an update on the FDA's COVID-19 response during the reporting period, as well as a new infographic providing a FDA COVID-19 response actions snapshot from the beginning of the public health emergency through the end of FY 2021.
- On March 16, the FDA released findings from a sampling assignment that collected and tested processed avocado and guacamole from November 2017 to September 2019. The assignment sought to estimate the prevalence of Salmonella spp and Listeria monocytogenes in processed avocado and guacamole. During the assignment the FDA collected and tested a total of 887 samples of both domestic and imported processed avocado and guacamole as part of the agency’s ongoing effort to proactively ensure food safety and prevent contaminated food from reaching consumers.
- As part of the FDA’s effort to protect consumers, the agency issued a warning letter to the operator of one website, Ivermectin24h.com for marketing misbranded drugs for treatment of multiple diseases, including COVID-19. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients or contain different ingredients altogether. Consumers can visit BeSafeRx to learn about how to safely buy medicine online. Consumers concerned about COVID-19 should consult with their health care provider.
- On March 16, the FDA issued an emergency use authorization (EUA) for PHASE Scientific International, Ltd.’s INDICAID COVID-19 Rapid Antigen At-Home Test, an OTC #COVID19 antigen diagnostic. The FDA is committed to increase the availability of appropriately accurate and reliable at-home COVID19 diagnostic tests, and to facilitate consumer access to these tests.
- On March 15, as part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Iotech International, LLC for selling unapproved products with unproven COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.
Today, the FDA COVID-19 testing updates:
- ·As of today, 422 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 290 molecular tests and sample collection devices, 84 antibody and other immune response tests and 48 antigen tests. There are 71 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, 15 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
- The FDA has authorized 28 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 882 revisions to EUA authorizations.
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