The U.S. Food and Drug Administration Tuesday announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
The FDA issued information on the use of serological (antibody) tests to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. This information includes:
Important Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care Providers;
FDA Fact Sheet - Serological Testing for Antibodies to SARS-CoV-2 Infection; and
New Serology/Antibody Test FAQs in the FAQs on Diagnostic Testing for SARS-CoV-2.
The FDA issued a face mask emergency use authorization (EUA) in response to concerns relating to insufficient supply and availability of face masks for use by members of the general public, including health care personnel in healthcare settings as personal protective equipment (PPE), to cover their noses and mouths, in accordance with Centers for Disease Control and Prevention (CDC) recommendations, to prevent the spread of the SARS-CoV-2 virus during the pandemic.
Manufacturers of face masks that are used as described in the EUA and meet the requirements in the EUA, do not need to take any action, other than complying with the Conditions of Authorization in the EUA, to be authorized under this EUA.