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Articles by U.S. Food and Drug Administration

FDA Approves First Non-Surgical Heart Valve to Treat Congenital Heart Disease

FDA Approves First Non-Surgical Heart Valve to Treat Congenital Heart Disease

U.S. Food and Drug Administration | March 31, 2021

New implant device provides option to treat pulmonary valve regurgitation in patients with right ventricular outflow tract

FDA Permits Marketing of First COVID-19 Diagnostic Test via De Novo Process

FDA Permits Marketing of First COVID-19 Diagnostic Test via De Novo Process

U.S. Food and Drug Administration | March 19, 2021

This is the first SARS-CoV-2 diagnostic test permitted to be marketed beyond the public health emergency

FDA Issues Alert Regarding SARS-CoV-2 Mutation to Clinical Laboratory Staff

FDA Issues Alert Regarding SARS-CoV-2 Mutation to Clinical Laboratory Staff

U.S. Food and Drug Administration | January 12, 2021

If mutations occur in the part of the virus’s genome assessed by a test, the mutations can cause false negative results

FDA Allows States to Authorize Coronavirus Tests

FDA Allows States to Authorize Coronavirus Tests

U.S. Food and Drug Administration | March 17, 2020

FDA provides more regulatory relief during outbreak, continues to help expedite availability of diagnostics