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Coronavirus Disease 2019 (COVID-19) updates
Updates from FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
Bookmark www.fda.gov/coronavirus for the latest.
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FDA updates COVID-19 test policies
Actions will help ensure accuracy and reliability of tests, increase access to at-home tests
On November 15, 2021, FDA announced several important actions to support ongoing nationwide COVID-19 testing efforts. These actions are aimed at further increasing access to accurate and reliable COVID-19 tests, particularly diagnostic tests that can be performed at home or in places like doctor’s offices, hospitals, urgent care centers, and emergency rooms without having to be sent to a central lab for testing. As part of this effort, FDA:
Also see: Statement by HHS Secretary Xavier Becerra on Withdrawal of HHS Policy on Laboratory-Developed Tests (LDTs). More information for test developers is available under EUA updates below.
COVID-19 vaccine updates
 Vaccine fact sheet translations
The revised Pfizer-BioNTech COVID-19 Vaccine Fact Sheets for Recipients and Caregivers are being posted in multiple languages as translations become available on the FDA web page Comirnaty and Pfizer-BioNTech COVID-19 Vaccine. Updated translations are now available in Spanish, Chinese (Simplified), Dari, Haitian Creole, Hmong, Khmer, Korean, Portuguese, Russian, Tagalog, Vietnamese, and Uzbek.
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Emergency Use Authorization (EUA) updates
Updated molecular and antigen home use test template
FDA posted an updated template intended to assist test developers and facilitate the EUA request and Pre-EUA submission processes for COVID-19 tests. The Molecular and Antigen Home Use Test Template (Word doc) includes updated recommendations and additional clarity for test developers, and is intended to help test developers provide validation data and other information to the FDA. Developers can use alternative approaches and can discuss them with the FDA. (November 9, 2021)
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Updated testing policies
FDA updated its policies regarding tests, including LDTs, currently being offered prior to or without authorization, as well as policies regarding the types of tests on which the FDA intends to focus its review. Moving forward, the FDA generally intends to focus its review on EUA requests for the following types of tests:
- At-home and point-of-care (POC) diagnostic tests for use with or without a prescription and that can be manufactured in high volumes;
- Certain high-volume, lab-based molecular diagnostic tests (and home collection kits for use with such tests) that expand testing capacity or accessibility such as through pooling of specimens to increase throughput, testing specimens collected at home and shipped to the lab, screening asymptomatic individuals or detecting multiple different respiratory viruses at once;
- Certain lab-based and POC high volume antibody tests that can measure the amount of antibodies (fully quantitative antibody tests) or the amount of neutralizing antibodies; and
- Tests for which the request is from, or supported by, a U.S. government stakeholder, such as the Biomedical Advanced Research and Development Authority (BARDA) or the National Institutes of Health’s Rapid Acceleration of Diagnostics (NIH RADx).
Developers of other tests may consider pursuing marketing authorization through traditional device review pathways such as 510(k) notification or De Novo classification. As discussed in the guidance reissued on November 15, 2021, Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised), FDA now generally expects newly offered COVID-19 tests, including LDTs, to have an EUA, or traditional marketing authorization such as a granted De Novo or cleared 510(k), prior to clinical use. (November 15, 2021)
New umbrella EUA for SARS-CoV-2 molecular diagnostic tests for serial testing
On November 15, 2021, FDA issued an umbrella EUA for certain RT-PCR molecular-based tests, developed by laboratories, for detection of nucleic acid from SARS-CoV-2 from anterior nasal respiratory specimens for use as part of a serial testing program, that meet certain criteria for eligibility specified in the EUA. Under this EUA, authorized tests can be used with individual or pooled anterior nasal specimens for testing individuals, including individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least once per week. Learn more
Ellume recalls COVID-19 Home Test for potential false positive SARS-CoV-2 test results
Ellume is recalling their COVID-19 Home Test because they have the potential to give false positive SARS-CoV-2 test results. For these tests, a false positive test result shows that a person has the virus when they do not have it. The recall described in this notice is for the same issue that was previously announced in the October 5, 2021, FDA Safety Communication: Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue. FDA has identified this as a Class I recall, the most serious type of recall. Use of these tests may cause serious adverse health consequences or death. (November 10, 2021)
In vitro diagnostic (test) EUAs
As of November 16, 2021, 422 tests and sample collection devices are authorized by FDA under EUAs. These include 293 molecular tests and sample collection devices, 90 antibody and other immune response tests, and 39 antigen tests. There are 66 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for molecular prescription at-home test, 3 EUAs for antigen prescription at-home tests, 10 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 19 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 685 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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November 17, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH). FDA will host additional events in this series December 1 and December 15, 2021.
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November 30, 2021: Antimicrobial Drugs Advisory Committee (AMDAC) meeting (webcast) - To discuss Merck and Ridgeback’s request for an EUA for molnupiravir, an investigational antiviral drug to treat COVID-19. The committee will discuss the available data supporting the use of molnupiravir to treat mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who have tested positive for COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
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December 7-8, 2021: Clinical Investigator Training Course (CITC) Update (virtual), including a review of the development and emergency use authorization of medical products for the prevention and treatment of COVID-19, and investigator responsibilities during the pandemic.
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Information for industry and health care providers
Report suspected fraudulent gloves to FDA
If you have purchased any medical gloves that are:
- Visibly soiled
- Are a different color
- Appear to have been used, or
otherwise seem to be fraudulent, please report it to the FDA by email to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.
Background: FDA is investigating certain imported medical gloves that appear to have been reprocessed, cleaned, or recycled and sold as new. FDA has determined that many foreign manufacturers and shippers of medical gloves have failed to consistently provide medical gloves of adequate quality for distribution in the United States. FDA recommends that health care facilities and providers do not purchase or use imported medical gloves from companies included on Import Alert 80-04 Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves. (October 29, 2021)
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FDA provides update on recall of certain Philips Respironics breathing assistance machines (CPAP and BiPAP)
FDA provided an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. This update provides additional information on the recall and recommendations for people who use repaired and replaced devices. At this time, the FDA is not changing the recommendations from the prior safety communication. This update also addresses common questions and concerns from consumers, patient organizations, and health care professional societies. As the FDA continues to work diligently on this recall and develop solutions, we will continue to share information with the public and provide additional recommendations to patients and health care providers. For more information, see the FDA news release. (November 12, 2021)
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
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.
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Why you should not use ivermectin to treat or prevent COVID-19
Some people are taking ivermectin, a drug often prescribed for animals, to try to prevent or treat COVID-19. FDA has not approved or authorized ivermectin for this use, and it can be dangerous for people. Information is also available in six additional languages.
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 250 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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Learn more about COVID-19 vaccines
Getting vaccinated to prevent COVID-19 will help protect you from COVID-19, and it may also protect the people around you. Learn about the evidence supporting FDA approval of Comirnaty and FDA emergency use authorization of COVID-19 vaccines.
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