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Food and Drug Administration and Compliance Issues
The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:
On July 28, 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 diagnostic tests that can be performed entirely outside of a laboratory, such as at home, in schools or in other non-lab settings.
To date, the FDA has currently authorized 193 tests under EUAs; these include 158 molecular tests, 33 antibody tests, and 2 antigen tests.