Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has taken action in the ongoing response to the COVID-19 Coronavirus pandemic:
On July 28th, the FDA updated the Molecular Diagnostic templates.
The Molecular Diagnostic templates include recommendations for laboratories and commercial manufacturers who may use the templates to help facilitate the preparation and submission of requests for emergency use authorizations (EUAs).
The updates are regarding diagnostic tests for use with sample pooling, at the point of care, and in the detection and differentiation of SARS-CoV-2 and other respiratory pathogens such as viruses that cause influenza.
Today, the FDA posted a new template for commercial manufacturers to help facilitate the preparation and submission of emergency use authorization (EUA) requests for prescription or non-prescription COVID-19 Coronavirus diagnostic tests that can be performed entirely outside of a laboratory, such as at home, in schools or in other non-lab settings.
Testing updates:
To date, the FDA has currently authorized 193 tests under EUAs; these include 158 molecular tests, 33 antibody tests, and 2 antigen tests.
About the U.S. Food and Drug Administration
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.
