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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:
- March 22, 2022: FDA Roundup including a Letter to Health Care Personnel to provide recommendations, including conservation strategies, for prefilled 0.9% sodium chloride IV lock/ flush syringes. Prefilled 0.9% sodium chloride IV lock/ flush syringes are in shortage because of an increase in demand during the COVID-19 public health emergency.
- March 21, 2022: Philips Respironics Recalls Certain V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm
- March 21, 2022: FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters
- March 18, 2022: FDA Roundup including warning letters to companies selling misbranded and unapproved drugs. Visit BeSafeRx to learn how to safely buy medicine online.
- March 18, 2022: Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety Communication
- March 18, 2022: Updated: At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
- March 17, 2022: New fact sheet: Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health (PDF)
- March 16, 2022: SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 vaccine updates
VRBPAC: April 6, 2022
FDA will hold a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on April 6, 2022, to discuss considerations for future COVID-19 vaccine booster doses and the process for selecting specific strains of the SARS-CoV-2 virus for COVID-19 vaccines to address current and emerging variants.
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COVID-19 test safety information
Use and store at-home COVID-19 tests properly to avoid potential harm
On March 18, 2022, 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.
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, when 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
New FAQs: At-home COVID-19 diagnostic tests
On March 18, 2022, FDA added the following frequently asked questions to the At-Home COVID-19 Diagnostic Tests Frequently Asked Questions page:
SD Biosensor recalls STANDARD Q COVID-19 Ag Home Tests that are not authorized, cleared, or approved by the FDA and may give false results
SD Biosensor Inc. is recalling its STANDARD Q COVID-19 Ag Home Tests because these tests were distributed to U.S. customers without authorization, clearance, or approval from the FDA. As this test was not authorized, cleared, or approved by the FDA, there is not sufficient data demonstrating that the test’s performance is accurate. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death. This recall does not apply to the SD Biosensor COVID-19 At-Home Test (PDF), which was authorized by the FDA on December 24, 2021. (March 16, 2022)
FDA fact sheet
Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health
This new fact sheet includes information on the medical device shortages authority and work on shortages undertaken in the FDA’s Center for Devices and Radiological Health (CDRH), including:
- What did the COVID-19 pandemic teach us about medical device shortages?
- What is CDRH’s current authority to help address the shortages?
- Will the shortages end with the pandemic?
- What will help prevent future shortages?
- What additional authority will CDRH need?
- How do these authorities help industry?
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Join FDA's Medical Countermeasures Initiative (MCMi)
Job opening: Regulatory counsel
This position is located in the FDA Office of the Chief Scientist, Office of Counterterrorism and Emerging Threats (OCET), which provides policy analysis and strategic coordination in crisis situations and extremely complex agency issues. More information is available in these USAJobs listings, which both close March 25, 2022:
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Emergency Use Authorization (EUA) updates
FDA authorizes another OTC antigen test
The INDICAID COVID-19 Rapid Antigen At-Home Test (PDF) is an over-the-counter (OTC) at-home COVID-19 antigen diagnostic test that delivers results in 20 minutes. For more information and a full list of authorized OTC tests, see: At-Home OTC COVID-19 Diagnostic Tests. (March 16, 2022)
EUA revocations
FDA revoked EUAs for these tests, at the request of their sponsors, for the reasons noted in the revocation letters:
Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information. For revoked device EUAs, see: Historical Information about Device Emergency Use Authorizations.
SARS-CoV-2 viral mutations: Impact on COVID-19 tests
Please bookmark and check this web page often for updates on how viral mutations, including the omicron variant, impact COVID-19 tests: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.
In vitro diagnostic (test) EUAs
As of March 22, 2022, 425 tests and sample collection devices are authorized by FDA under EUAs. These include 293 molecular tests and sample collection devices, 84 antibody and other immune response tests, and 48 antigen tests. There are 75 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for 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 EUAs for molecular OTC at-home tests. FDA has authorized 28 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 892 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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March 23, 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 hold additional events in this series on April 6 and April 20, 2022.
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March 23-24, 2022: FDA Public Meeting: Identification of Concepts and Terminology for Multi-Component Biomarkers (virtual, 1:00 - 3:00 p.m. ET both days) - This workshop is intended to develop multi-component biomarker concepts and terminology, to identify areas of conceptual language development through presentation of use cases, and discuss gaps in terminology for concepts and approaches related to multi-component biomarkers. Register to receive an email with instructions on how to join this event.
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New! April 6, 2022: Vaccines and Related Biological Products Advisory Committee Meeting (virtual) - To discuss considerations for future COVID-19 vaccine booster doses and the process for selecting specific strains of the SARS-CoV-2 virus for COVID-19 vaccines to address current and emerging variants. Also see: FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters
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April 25-29, 2022: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - register by March 25, 2022
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Information for industry and health care providers
Expiration dating extension
Did you know? You can find information about shelf-life extensions of COVID-19 vaccines, therapeutics, and in vitro diagnostic (IVD) tests on our web page: Expiration Dating Extension, under MCM Expiration Dating Extensions. On March 18, 2022, we added additional information about shelf-life extensions for COVID-19 IVDs.
Philips Respironics recalls certain V60 and V60 Plus ventilators for expired adhesive that may cause ventilator to stop working with or without an alarm
Philips Respironics is recalling certain V60 and V60 Plus ventilators because a subset of these devices had parts that were assembled using an expired adhesive. If the adhesive fails, it could cause the ventilator to stop providing oxygen to the patient. This failure may cause an alarm to notify the health care provider, or it may not sound any alarm at all. FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death. (March 21, 2022)
Prefilled Saline Flush Syringe Conservation Strategies - Letter to Health Care Personnel
FDA issued a Letter to Health Care Personnel to provide recommendations, including conservation strategies, for prefilled 0.9% sodium chloride IV lock/ flush syringes.
The FDA is aware the United States is experiencing interruptions in the supply of prefilled 0.9% sodium chloride (saline) intravenous (IV) lock/ flush syringes. Prefilled 0.9% sodium chloride IV lock/ flush syringes are in shortage because of an increase in demand during the COVID-19 public health emergency, as well as recent vendor supply chain challenges, including the permanent discontinuance of certain prefilled saline lock/ flush syringes.
FDA has added prefilled 0.9% sodium chloride IV lock/flush syringes (product code NGT – Saline, Vascular Access Flush) to the device shortage list and the device discontinuance list. FDA also added certain discontinued surgical apparel (product codes FME, FXP, FYF, LYU, and OEA) to the device discontinuance list. (March 21, 2022)
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
FDA COVID-19 response infographic
View a snapshot of some FDA COVID-19 response actions from the beginning of the public health emergency through the end of FY 2021. A downloadable PDF and text version of this infographic are available.
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Find a COVID-19 vaccine or booster near you
Text your zip code to GETVAX (438829) in English or VACUNA (822862) in Spanish to find out where COVID-19 vaccines are available near you. COVID-19 vaccines are free to all people living in the United States, regardless of their immigration or health insurance status. Learn more at vaccines.gov.
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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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