FDA authorizes marketing SARS-CoV-2 test beyond the public health emergency

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FDA authorizes marketing SARS-CoV-2 test beyond the public health emergency
tjordan_drupal
Mar 18, 2021

For the first time, the Food and Drug Administration yesterday authorized marketing a SARS-CoV-2 diagnostic test beyond the public health emergency based on additional data. FDA previously authorized the BioFire Respiratory Panel 2.1 test for emergency use to detect SARS-CoV-2 and other respiratory pathogens in individuals with suspected COVID-19.

“While this is the first marketing authorization for a [COVID-19] diagnostic test using a traditional premarket review process, we do not expect this to be the last and look forward to working with developers of medical products to move their products through our traditional review pathways,” said FDA Acting Commissioner Janet Woodcock, M.D.

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FDA authorizes marketing SARS-CoV-2 test beyond the public health emergency
tjordan_drupal
Mar 18, 2021

For the first time, the Food and Drug Administration yesterday authorized marketing a SARS-CoV-2 diagnostic test beyond the public health emergency based on additional data. FDA previously authorized the BioFire Respiratory Panel 2.1 test for emergency use to detect SARS-CoV-2 and other respiratory pathogens in individuals with suspected COVID-19.

“While this is the first marketing authorization for a [COVID-19] diagnostic test using a traditional premarket review process, we do not expect this to be the last and look forward to working with developers of medical products to move their products through our traditional review pathways,” said FDA Acting Commissioner Janet Woodcock, M.D.

Novel Coronavirus (SARS-CoV-2/COVID-19)
COVID-19: CDC, FDA and CMS Guidance

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