NEW YORK – The US Food and Drug Administration said on Tuesday that it is updating its policy on Emergency Use Authorizations for COVID-19 tests and limiting its review of new submissions.
According to a statement posted on the agency's website, the FDA will only review a small subset of new EUA requests and is encouraging test developers to pursue authorization through either the de novo classification or 510(k) clearance premarket review pathways.
The agency said it will focus its review on requests from experienced developers for diagnostic tests that are likely to have a significant benefit to public health, such as ones that rely on new technologies, or tests that are likely to fulfill an unmet need, including diagnosing a new variant. It will also focus on "supplemental EUA requests for previously authorized tests when the request is intended to fulfill a condition of authorization or includes a modification that will significantly benefit public health or fulfill an unmet need," the FDA said.
In addition, the FDA will review requests from or supported by a US government stakeholder, including tests funded by the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority or the National Institutes of Health's Rapid Acceleration of Diagnostics program.
"Taking into account the current status of manufacturing capacity and consumer access given the [Biden] 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," Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "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."