New Medical Countermeasures Initiative report and COVID-19 response infographic

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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 16, 2022: FDA published the MCMi FY 2021 Program Update report and a new COVID-19 response infographic March 15, 2022: FDA Roundup including a warning letter issued jointly with the Federal Trade Commission to a company for selling unapproved products with fraudulent COVID-19 claims March 11, 2022: FDA Roundup including a warning letter issued jointly with the Federal Trade Commission to a company for selling unapproved products with fraudulent COVID-19 claims March 10, 2022: FDA Orders Philips Respironics to Notify Patients Regarding the Recall of Certain Breathing Assistance Machines Bookmark www.fda.gov/coronavirus for the latest.

MCMi program update

Annual report on FDA's work to support medical countermeasure-related public health preparedness and response efforts Today FDA published the Medical Countermeasures Initiative (MCMi) Program Update report which showcases FDA's work each year to prepare for all types of public health emergencies, including COVID-19. This report, covering fiscal year 2021, includes an update on FDA's COVID-19 response during the reporting period. Download a printable PDF. (March 16, 2022)

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 recall

LuSys Laboratories, Inc recalls COVID-19 tests

LuSys Laboratories, Inc is recalling COVID-19 antigen (nasal/saliva) and COVID-19 IgG/IgM antibody tests because they do not have an EUA, 510(k) premarket notification, or premarket approval (PMA) and therefore cannot be marketed and distributed in the U.S. The risks include potential false negative, false positive, and misinterpretation of results from these tests. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The devices described in this recall notice are the same ones that were identified in the FDA safety communication, Stop Using LuSys Laboratories COVID-19 Tests, from January 2022. (March 14, 2022)  

Emergency Use Authorization (EUA) updates

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 15, 2022, 422 tests and sample collection devices are authorized by FDA under EUAs. These include 290 molecular tests and sample collection devices, 85 antibody and other immune response tests, and 47 antigen tests. There are 70 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, 14 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 25 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 876 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics

Events

• March 16-17, 2022: Virtual Public Workshop - 3D Printing in Hospitals: Veteran’s Health Administration’s Experiences in Point of Care 3D Printing of Device and Implementing a Quality Management System - FDA is hosting a virtual public workshop in collaboration with the Veteran’s Health Administration (VHA) to share VHA’s experiences using 3D printing/additive manufacturing in their hospitals. The workshop is also intended to provide a forum for VHA and other stakeholders to present and discuss their experience that could be useful for health care facilities considering 3D printing medical devices. 

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

Information for industry and health care providers

Shelf life extension: Janssen COVID-19 Vaccine

On March 4, 2022, FDA authorized an extension (PDF) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, from six to nine months, allowing the product to be stored at 2-8 degrees Celsius.  This extension was granted following a thorough review of data submitted by Janssen, now applying to all refrigerated vials of Janssen COVID-19 Vaccine that have been held in accordance with the manufacturer’s storage conditions. Health care providers administering the vaccine should check the company’s website (https://vaxcheck.jnj) to obtain the most up-to-date expiration dates for specific lots of the Janssen COVID-19 vaccine. 

FDA orders Philips Respironics to notify patients regarding the recall of certain breathing assistance machines

On March 10, 2022, FDA issued a notification order (PDF) to Philips Respironics requiring the company to notify patients and others of the company’s June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products. The FDA has determined that this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company’s notification efforts to date have been inadequate. Also see: How to Tell if Your Device Has Been Recalled and What to Do Next 

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.

In case you missed it

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.

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.

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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FDA Medical Countermeasures Initiative (MCMi) News)