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FDA Releases Guidance on COVID-19 Tests Transitioning to Full Market Authorization

NEW YORK – The US Food and Drug Administration this week released its guidance document for developers of medical devices for COVID-19, including diagnostic tests, on how to transition from Emergency Use Authorization to full marketing and regulatory authorization.

The guidance closely mirrors draft guidance that the agency released in December 2021 and comes as the FDA winds down the EUA process for COVID-19 tests and test developers apply for full regulatory authorization for any new tests. The agency also wants developers with tests that already have EUA to apply for full regulatory clearance, a more rigorous process, for those tests. Since the start of the pandemic in early 2020, the FDA has allowed companies to market their COVID tests after they received EUA.

So far, only a small handful of COVID-19 tests have received full FDA authorization, the most recent being an antigen test from QuidelOrtho. Last May, some experts told 360Dx that some companies may decide against bringing their COVID-19 tests to market after the FDA terminates the EUA process for them.

On Wednesday, in her newsletter covering the diagnostic testing landscape, Mara Aspinall, a professor of practice at the Arizona State University College of Health Solutions and adviser to the Rockefeller Foundation on COVID-19, also said she believes many existing firms with COVID-19 tests that received EUA will not seek full marketing approval for those tests.

The FDA has not yet set a date for when tests that have received EUA will have those authorizations terminated, but the Biden administration had said it will end the COVID-19 public health emergency on May 11, and on Wednesday the Senate voted to end the emergency even earlier. The bill is now headed to Biden, and if he signs it, the termination of EUAs could soon follow. 

The agency also has not set a date for the termination of the EUAs but said it will provide test developers 180 days' notice beforehand and noted in the guidance that it will not "object to the continued distribution" of tests that have received EUA if the developer has applied a marketing submission to the agency for the test and the FDA has not reached a final decision on the submission.

The FDA also said that following the termination of the EUAs that it "intends to have the same enforcement approach for COVID-19 [laboratory-developed tests] as it does for other LDTs," noting that while it has enforcement discretion to regulate such tests — which the lab industry disputes — it has generally not done so.

Aspinall said in her newsletter that several questions remain even with the FDA guidance, including how quickly the agency would process submissions from firms trying to move their tests from EUA status to full marketing approval, and whether "the bolus of applications from EUAs slow the process for other diagnostic test approvals."

Also unanswered is whether the EUA process and the upcoming transition process would "usher in a new era of home testing," she added.