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FDA Asks COVID Test Makers to Switch from Emergency to Premarket Approvals

The US FDA has announced that manufacturers of new COVID-19 tests should now follow traditional premarket pathways.

US FDA formally proposes aligning Quality System Regulations with ISO 13485

December 6, 2022

The US Food and Drug Administration (FDA) announced that it has begun requiring manufacturers to seek premarket approvals rather than emergency use authorizations (EUAs) for certain new COVID-19 tests, effective immediately.

Now that infection numbers are at more manageable levels, the FDA has determined that EUAs are no longer a necessity for a large percentage of new COVID-19 test reviews. FDA seeks to review fewer of them as a result. Except in certain cases, COVID-19 test makers must now pursue traditional premarket pathways.

COVID-19 test manufacturers may consult the Centers for Devices and Radiological Health revised policy for getting tests approved during the public health emergency. The document supersedes the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Guidance for Developers and Food and Drug Administration Staff dated November 15, 2021.

How is the market approval landscape changing for COVID test makers?

The FDA has said it will prioritize the review of new COVID-19 tests that would fill an unmet need, such as a test that diagnoses a new variant or subvariant of the disease. The agency will continue to review emergency authorizations that meet a condition of the EUA. Tests produced with funding from key government stakeholders will also be prioritized for review.

If none of the conditions for an EUA are met by a new COVID-19 test, the manufacturer should pursue the traditional premarket pathway to obtain marketing approval.

According to FDA, going forward, experienced COVID test developers can use EUAs if any of the following conditions are met:

  • The diagnostic tests are likely to have a significant benefit to public health (such as those that use new technologies).
  • Diagnostic tests that are likely to fill 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.
  • 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).

What else do manufacturers need to know about the new premarket guidance?

An FDA news release states that more than 400 EUAs have been granted to COVID-19 test makers as of August 2022. “Testing remains one of the key pillars in combatting the COVID-19 pandemic,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Taking into account the current status of the 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,” Shuren said.

Manufacturers seeking to follow a traditional premarket pathway should pursue either a de novo classification or 510(k) clearance premarket review pathway.

Emergo by UL will continue to post updates to FDA guidance as they become available.