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FDA Office of Minority Health and Health Equity

Coronavirus Disease 2019 (COVID-19) updates

Updates from FDA in our ongoing response to the COVID-19 pandemic since our last 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.

COVID-19 vaccine update

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.

COVID-19 response infographic FDA also published a new infographic providing 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 are available. (March 16, 2022)

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:

• 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?

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?

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:

• Regulatory Counsel (GS-12/13)
• Regulatory Counsel (GS-14)

Events

• 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.
• 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.
• 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
• April 25-29, 2022: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - register by March 25, 2022

In case you missed it

MCMi Program Update FY 2021 The Medical Countermeasures Initiative (MCMi) Program Update report showcases FDA's work each year to prepare for all types of public health emergencies, including COVID-19.

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.

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.

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.

Find additional coronavirus disease 2019 (COVID-19) updates on our website and in the Medical Countermeasures Initiative newsletter.

Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity

"Creating a world where health equity is a reality for all." www.fda.gov/healthequity