The U.S. FDA has taken the following action as of May 8 in the ongoing response effort to the COVID-19 pandemic: 

• The FDA authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing. Specifically, the FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory developed test (LDT), which had been previously authorized under the high complexity molecular-based LDT “umbrella” EUA, to permit testing of samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device.
    
• The FDA issued an updated At-A-Glance that provides a quick look at facts, figures and highlights of agency’s response efforts. 
    
• The FDA and Federal Trade Commission (FTC) issued warning letters to four companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. 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.

• The FDA issued an EUA for the Duke Decontamination System for use in decontaminating compatible N95 or N95-equivalent respirators for reuse by health care personnel when there are insufficient supplies of these respirators resulting from the COVID-19 pandemic. This is the sixth respirator decontamination system FDA has authorized for emergency use during this pandemic and the second based on public health emergency preparedness research funded by FDA. 

• The FDA approved an Abbreviated New Drug Application for lidocaine hydrochloride injection USP, 1%, which is indicated for production of local or regional anesthesia and a drug listed in the FDA Drug Shortage Database. FDA recognizes the increased demand for certain products during the novel coronavirus pandemic and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.
    
• Diagnostics update to date: 
  • During the COVID-19 pandemic, the FDA has worked with more than 385 test developers who have said they will be submitting EUA requests to the FDA for tests that detect the virus. 
  • To date, the FDA has issued 65 individual EUAs for test kit manufacturers and laboratories. In addition, 25 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs). 
  • The FDA has been notified that more than 245 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.