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Coronavirus Disease 2019 (COVID-19) updates
Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
- March 23, 2021: COVID-19 Update including a warning letter to a company selling unapproved products with fraudulent COVID-19 claims
- March 19, 2021: FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 Infection
- March 19, 2021: COVID-19 Update including a web page with screening information for newly established testing programs
- March 18, 2021: FDA’s Ongoing Use of Inspectional Tools for Ensuring Access to Safe, Quality Food and Medical Products During the COVID-19 Pandemic
- March 18, 2021: Examining Our Covid-19 Response: An Update From Federal Officials - Congressional testimony by Peter Marks, M.D., Ph.D., Director, FDA Center for Biologics Evaluation and Research (CBER)
- March 17, 2021: FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process
- March 17, 2021: Leading the Way Forward: Biden Administration Actions to Increase Covid-19 Vaccinations - Congressional testimony by Peter Marks, M.D., Ph.D., Director, FDA CBER
Bookmark www.fda.gov/coronavirus for the latest.
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 Help stop the spread of coronavirus and protect your family
The COVID-19 pandemic requires that we remain vigilant in our daily lives until we can safely return to everyday activities. We can each take some simple steps to help slow the spread of coronavirus disease and protect ourselves, our families, and our communities.
The steps are:
- Get a COVID-19 vaccine.
- Wash your hands often with plain soap and water.
- Cover your mouth and nose with a mask when around others.
- Avoid crowds and practice social distancing (stay at least 6 feet apart from others).
 FDA permits marketing of first SARS-CoV-2 diagnostic test using traditional premarket review process
FDA granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1) (PDF), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections.
The diagnostic test, which had an Emergency Use Authorization (EUA), was granted marketing authorization using the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
The grant of this De Novo request marks an important step in FDA’s response to the COVID-19 pandemic because it is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency. (March 17, 2021)
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Emergency Use Authorization (EUA) updates
COVID-19 serology EUA templates for test developers
FDA posted two templates with recommendations on what to include in EUA requests or Pre-EUA submissions for serology tests.
These templates provide the FDA’s current recommendations concerning what data and information should be submitted to the FDA in support of an EUA request or Pre-EUA submission for SARS-CoV-2 antibody tests. The templates are intended to help test developers provide validation data and other information to the FDA, but alternative approaches can be used. (March 17, 2021)
FDA authorizes first machine learning-based screening device to identify certain biomarkers that may indicate COVID-19 infection
FDA issued an EUA (PDF) for the first machine learning-based COVID-19 non-diagnostic screening device that identifies certain biomarkers that are indicative of SARS-CoV-2. Read more (March 19, 2021)
For health care providers: FDA authorizes revisions to fact sheets to address SARS-CoV-2 variants for monoclonal antibody products under EUA
FDA authorized revised fact sheets for health care providers to include additional information on susceptibility of SARS-CoV-2 variants to each of the monoclonal antibody (mAb) therapies that are available through an EUA for the treatment of COVID-19. FDA is providing this information to equip health care providers with the most current data so they can make informed decisions and provide appropriate care to patients with COVID-19. Health care providers should review the fact sheets for details regarding specific variants and potential resistance that may make the authorized mAb therapies less effective.
The revised PDF fact sheets are for:
The fact sheet revisions provide additional information to health care providers concerning how certain variants of SARS-CoV-2, known to be circulating within the United States, may impact the effectiveness of the authorized mAb therapies. The revisions include information on the following variants: B.1.1.7 (UK Origin), B.1.351 (South Africa Origin), P.1 (Brazil Origin), B.1.427/B.1.429 (California Origin), and B.1.526 (New York Origin). Read more
(March 18, 2021)
Diagnostic test EUAs
As of today, 343 tests and sample collection devices are authorized by FDA under EUAs. These include 255 molecular tests and sample collection devices, 73 antibody and other immune response tests, and 15 antigen tests. There are 41 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, one over-the-counter (OTC) at-home antigen test, and one OTC molecular test. Also see: Coronavirus Testing Basics
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Events
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Today! March 24, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET - During the virtual town hall for SARS-CoV-2 test developers, the FDA will share information and answer your questions about the development and validation of tests for SARS-CoV-2. Registration is not required. If you are unable to attend the live virtual town hall, the recording and transcript will be available for viewing the Tuesday after the live event. There will be an opportunity to ask questions live on the call, but questions may also be submitted in advance by emailing CDRHWebinars@fda.hhs.gov. FDA will host an additional webinar in this series on March 31, 2021.
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May 26-27, 2021: Save the date! 2021 FDA Science Forum: Science as the Foundation for Protecting and Promoting Public Health (virtual) - FDA scientific experts and nationally renowned scientists will discuss eight topic areas including one on medical countermeasures, infectious disease, and pathogen reduction technologies. This year’s keynote speaker is NIAID Director Anthony Fauci, MD.
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Information for industry
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 70 COVID-19-related guidances to date.
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In case you missed it
COVID-19 vaccines - more languages
Janssen COVID-19 Vaccine fact sheets for recipients and caregivers are now available in 27 languages. Get the latest information about FDA-authorized COVID-19 vaccines: www.fda.gov/covid19vaccines
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FDA is vigilant in protecting consumers against COVID-19 vaccine scams
Consumers should know the COVID-19 vaccines that the FDA has authorized for emergency use cannot be sold online. Legitimate COVID-19 vaccines are being distributed for free. Learn more
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 225 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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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 Spanish, Portuguese, Simplified Chinese, Korean, Vietnamese and Tagalog.
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