FDA permits marketing of COVID-19 test using De Novo pathway

BioFire Respiratory Panel 2.1 detects 22 viruses and bacteria associated with respiratory tract infections, including SARS-CoV-2.

If your email program has trouble displaying this email, view as a webpage. COVID-19 Update: FDA Permits Marking of First COVID-19 Diagnostic Test Using the De Novo Review Pathway Today, the U.S. Food and Drug Administration (FDA) granted BioFire Diagnostics LLC marketing authorization for its BioFire Respiratory Panel 2.1 diagnostic test. The grant of this De Novo request marks an important step in the FDA's response to the COVID-19 pandemic because it is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency.  The BioFire Respiratory Panel 2.1: Is a multi-analyte molecular test that simultaneously detects 22 different viruses and bacteria associated with respiratory tract infections, including SARS-CoV-2, from a single nasopharyngeal swab. Is for use only for people suspected of respiratory tract infections, including COVID-19.  Should be used by health care providers in combination with a clinical examination and consideration of patient medical history. Was granted marketing authorization using the De Novo premarket review pathway, meaning the FDA determined that special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for the device. Read More Questions? If you have questions, please email COVID19DX@fda.hhs.gov.

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