The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA issued two new emergency use authorizations (EUAs) for serology tests to detect for the presence of coronavirus antibodies. The EUAs were issued to Ortho-Clinical Diagnostics, Inc. for its VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Chembio Diagnostic Systems, Inc. for its DPP COVID-19 IgM/IgG System.
- The FDA issued an emergency use authorization (EUA) for the emergency use of Stryker Instrument’s Sterizone VP4 Sterilizer1 N95 Respirator Decontamination Cycle for use in decontaminating compatible N95 and N95-equivalent respirators for single-user reuse by healthcare personnel.
- The FDA has posted a new “At-a-Glance Summary” that captures the agency’s major activities in the fight against COVID-19. The agency intends to regularly update this resource on efforts related to medical products and equipment, vaccines and therapeutics, food supply and more.
- Yesterday, the FDA issued guidance on digital health devices for treating psychiatric disorders to help expand the availability of these devices while reducing user and health care provider contact and potential exposure to COVID-19 during this pandemic. The enforcement policy described in the guidance applies to computerized behavioral therapy devices and other digital health therapeutic devices for psychiatric disorders as well as low-risk general wellness and digital health products for mental health or psychiatric conditions.
- The FDA and Federal Trade Commission (FTC) issued a warning letter to one company for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. The seller warned, Earth Angel Oils, offers essential oil products that are unapproved and misbranded drugs for the prevention and treatment of COVID-19. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
- Diagnostics update to date:
- During the COVID-19 pandemic, the FDA has worked with more than 315 test developers who have said they will be submitting emergency use authorization (EUA) requests to FDA for COVID-19 tests.
- To date, 36 emergency use authorizations have been issued for COVID-19 tests.
- The FDA has been notified that more than 190 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
- The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.