FDA changes Covid-19 test policy to cut EUA requests

The U.S. Food and Drug Administration (FDA) has updated its Covid-19 test policy to make sure continued test access is still available while encouraging transition of the tests to traditional premarket review pathways.

The FDA intends to review a small subset of new emergency use authorization (EUA) requests for diagnostics tests. Developers of all test types should pursue authorization through a de novo or 510(k) premarket review pathway, the agency said.

“Testing remains one of the key pillars in combatting the Covid-19 pandemic,” Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health told the press. “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.”

To date, according to FDA, over 430 distinct Covid-19 tests were issued EUAs. Pending EUA authorization requests prior to the announcement will remain in the review queue.

Moving forward, the FDA intends to focus review on EUA requests and supplemental EUA requests from experienced developers for:

• Diagnostic tests likely to have a significant benefit to public health (such as those that employ new technologies);
• Diagnostic tests likely to fulfill an unmet need (such as diagnosing infection with a new variant or subvariant);
• 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; and
• Tests for which the EUA request is from (or supported by) a U.S. government stakeholder, such as tests funded by the Biomedical Advanced Research and Development Authority (BARDA) or the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx).

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