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Emergency Use Authorization (EUA) updates
New mpox diagnostic EUA
FDA issued an EUA (PDF) to DiaCarta, Inc. for the QuantiVirus MPXV Test Kit for the qualitative detection of DNA from monkeypox [mpox] virus in human lesion swab specimens from individuals suspected of mpox by their health care provider. Emergency use of this test is limited to authorized laboratories. For more information, see: Monkeypox (mpox) Emergency Use Authorizations for Medical Devices. (January 10, 2023)
COVID-19 in vitro diagnostic (test) EUAs
As of January 17, 2023, 443 tests and sample collection devices are authorized by FDA under EUAs. These include 298 molecular tests and sample collection devices, 85 antibody and other immune response tests, 59 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, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 EUAs for molecular OTC at-home tests. FDA has authorized 43 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,203 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics
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Information for industry and health care providers
FDA updates COVID-19 testing guidances to reflect duration of EUA declaration
FDA made minor updates to two COVID-19 testing guidances to help ensure continued access to tests while encouraging the transition of these important public health tools to traditional premarket review pathways.
The updated guidances are:
The minor updates to these guidances reflect FDA’s intent for the two guidances to remain in effect for the duration of the declaration under section 564 of the Federal Food, Drug, and Cosmetic Act that circumstances exist justifying Emergency Use Authorization of in vitro diagnostics for the detection of COVID-19, rather than the duration of the public health emergency determination under section 319 of the Public Health Service Act relating to COVID-19. FDA also made minor edits to the Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests guidance to reflect current information about variants and actions the FDA has taken since the original issuance of this guidance. (January 12, 2023)
FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 75 COVID-19-related guidances to date.
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In case you missed it
What happens to EUAs when a public health emergency ends?
There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ.
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It's a good time to get your flu vaccine
Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now can lower your chances of getting the flu. Find a flu shot near you. (Tip: You can get your updated COVID-19 vaccine booster at the same time!)
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 350 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.
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(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)
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