COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

COVID-19 Briefings

Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

In a New First, FDA Permits Marketing of COVID-19 Test Through Traditional Premarket Review Process

FDA maze of regulations

The FDA grants post-pandemic marketing authorization for COVID-19 test

For the duration of the pandemic, COVID-19 tests have received authorization to be used within the United States, relying exclusively on emergency use authorizations (EUAs). While effective in bringing tests to market quickly, these EUAs are only valid while the public health emergency is in effect, and tests operating under an EUA will not be authorized for use once the public health emergency is declared over.

However, in a new first, the US Food and Drug Administration (FDA) has granted its first authorization through traditional premarket review process, for a COVID-19 test. The BioFire Respiratory Panel 2.1 (RP2.1) had previously received and was operating under an EUA, but the test has now gained marketing approval under the FDA’s De Novo premarket review pathway. This means that this test is permitted to be marketed beyond the expiration of the public health emergency.

Todays action is a great demonstration of the FDAs work to protect the public health in emergency response situations and beyond,” said FDA Acting Commissioner Janet Woodcock, MD We ensured there were tests made available quickly under EUA; and we continue to work with diagnostic manufacturers to take the next step of ensuring products are FDA reviewed for safety and effectiveness and authorized for marketing under our traditional premarket authorities. While this is the first marketing authorization for a 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.”

While the BioFire Respiratory Panel 2.1 is now the first COVID-19 test to be De Novo authorized, the test’s EUA now revoked, clinical laboratory leaders should expect many more COVID-19 tests will gain such authorization for marketing beyond the public health emergency.

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