Devices

FDA Changing Covid Test Review Policy

FDA is changing its Covid-19 test policy to reduce the number of tests reviewed for an emergency use authorization (EUA) and increase the number of tests authorized through the traditional de novo classification or 510(k) clearance pathways. In an online statement, FDA says more than 430 distinct Covid-19 tests have been granted EUAs.

“The available information indicates that these tests are providing sufficient testing capacity for Covid-19 tests throughout the United States,” the statement says. “Recognizing the current testing capacity, at this time, the agency believes most future submissions are best suited for traditional premarket review pathways.”

FDA says it will now 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, such as employing new technologies;
diagnostic tests that are 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 is from or supported by a U.S. government stakeholder.

“FDA believes these priorities are appropriate to address the public health needs at the current stage of the Covid-19 public health emergency and may adjust these priorities as public health needs change,” the notice says. “FDA encourages test developers to consider these priorities and to otherwise shift their focus to traditional premarket review pathways for tests already authorized under EUA and new tests of the same types as those already available under EUA.”

Download the updated test policy here.

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