USA – FDA wants COVID test developers to shift from EUAs to traditional premarket pathways

The US Food and Drug Administration (FDA) has released updated guidance on COVID-19 diagnostic and serology testing, signaling its intention to review fewer emergency use authorizations (EUAs) for new tests moving forward.

FDA said it will now focus on reviewing EUA requests and supplemental EUA requests for COVID-19 tests that are “likely to have a significant public health benefit” or that would “fulfill an unmet need,” such as products that use innovative health technology or that would identify a new SARS-CoV-2 variant or subvariant. The agency will continue to review supplemental EUA requests for COVID-19 tests with existing EUAs “that fulfill a condition of an EUA,” the agency said.

COVID-19 tests developed by or with funding from government stakeholders such as the Biomedical Advanced Research and Development Authority (BARDA) or the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) will also be prioritized moving forward…