May 08, 2020: The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
The U.S. Food and Drug Administration 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.
This announcement builds on last month’s EUA for the first diagnostic test with a home-collection option, which uses a sample collected from the patient’s nose with a nasal swab and saline.Today, FDA issued two documents designed to assist retail food establishments that might have been closed or partially closed during the COVID-19 pandemic in preparing to reopen. The checklist and infographic documents are designed to help businesses that prepare food to serve or sell to the public directly, such as restaurants, bakeries, bars and carry-outs, protect employee and public health as they reopen for business.
Today, 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.
Yesterday, 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.
Yesterday, 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:
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.
