FDA Updates COVID-19 Test Policy; Asks Developers To Seek Premarket Review Pathways

The U.S. Food and Drug Administration said it now intends to review only a small subset of new emergency use authorization or EUA requests for diagnostic tests.

As per an updated COVID-19 test policy with a view to ensure continued access to tests, the regulator further urged developers of all test types seeking marketing authorization to pursue traditional premarket review for most test types.

The policy change seeks the transition of these important public health tools to traditional de novo classification or 510(k) clearance pre-market review pathways.

The FDA said it is revising the policy to update the types of COVID-19 tests for which the agency intends to review EUA requests. It will discuss the use of the traditional premarket review pathways for COVID-19 tests.

As of now, more than 430 distinct COVID-19 tests have been issued EUAs, and these tests provide sufficient testing capacity for COVID-19 tests throughout the United States.

The U.S. currently has the capacity for authorized manufacturers to produce hundreds of millions of tests per month.

However, the pending EUA authorization requests for tests already submitted will remain in the queue, it said.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said, “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.”

Moving forward, the FDA generally intends to focus its review on EUA requests and supplemental EUA requests from experienced developers for diagnostic tests that are likely to have a significant benefit to public health, as well as to fulfill an unmet need.

The agency will also focus on supplemental EUA requests for certain previously authorized tests and tests for which the EUA request is from or supported by a U.S. government stakeholder.

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