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

Regulatory NewsRegulatory News | 27 September 2022 |  By 

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.
Developers of diagnostic tests that don’t meet these criteria for EUA review should shift to traditional premarket review pathways for these products, the agency said in the updated final guidance.
In total, FDA has issued an EUA for more than 439 COVID-19 diagnostic and serology tests as of August 2022, the agency said in a Federal Register notice. Citing its January 2017 guidance on EUAs for medical products and related authorities, FDA said it “has and continues to prioritize among the EUA requests it receives for COVID-19 tests” to address public health priorities.
While access to validated testing is important during a public health emergency, FDA said it has “continued to closely monitor the COVID-19 testing landscape and believes it is appropriate to update its policies to reflect the current needs of the pandemic.”
“Testing remains one of the key pillars in combatting the COVID-19 pandemic,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, stated in a press release. “Taking into account the current status of manufacturing capacity and consumer access given the Administration’s important investments in tests, for most new tests, shifting to traditional premarket review would best meet the public health needs at the current stage of the COVID-19 public health emergency. The FDA will continue to offer support and expertise to assist with the development of accurate and reliable tests, and to facilitate continued access to tests for all Americans.”
Other elements of the guidance remain unchanged, such as US states or territories using their own COVID-19 testing and validation in Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories without submitting data or an EUA request to FDA. The agency also does not intend to object to CLIA-certified laboratories that modify COVID-19 tests under EUA if the modification does not change the indication for use of the test.
“In such cases, where the laboratory performing the modified test is not the developer of the original, EUA-authorized test, FDA encourages the laboratory to share its validation data with the developer of the original, EUA-authorized test so that the developer of the original, EUA-authorized test can use the validation data in support of a supplemental EUA request to add the modification or can incorporate it into a future submission through the traditional premarket review pathways,” the agency wrote.
Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)

Federal Register notice


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