FDA Updates COVID-19 Test Policy; Shifts Focus From EUAs
As part of a policy revamp, FDA encourages COVID-19 test developers to pursue traditional premarket review pathways rather than emergency use authorizations.
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A review by a government watchdog found the FDA’s review process for COVID-19 diagnostics was plagued by issues including allowing low-quality tests to slip through, high reviewer workloads, and manufacturer frustration.
Agency issued an emergency use authorization to Labcorp for its OTC that detects COVID-19, flu and respiratory syncytial virus.
The US Food and Drug Administration recently updated the labeling of Abiomed’s Impella RP System to reflect the latest results from a clinical study on the device. The FDA first approved the heart pump system in September 2017.