FDA discontinues Emergency Use Authorization reviews for laboratory developed tests

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During the Oct. 7, 2020, Food and Drug Administration (FDA) Virtual Town Hall live guidance, Director Timothy Stenzel announced that the FDA would not be issuing any further SARS-CoV-2 Emergency Use Authorizations (EUA) for laboratory developed tests (LDTs). The FDA’s stated goal in making the decision to end LDT EUA reviews is to improve testing capacity by prioritizing its resources for certain tests to increase the public health benefit.

The FDA updated its FAQs on Testing for SARS-CoV-2 to explain that the FDA is now in a different phase of the pandemic. Due to the FDA not requiring premarket review of LDTs, it is looking to prioritize review of EUA submissions for more widely distributed SARS-CoV-2 tests, including but not limited to:

  • Point of care tests
  • Home collection tests
  • At-home tests
  • High-throughput tests
  • Tests reducing reliance on supplies

Director Stenzel indicated that any labs who had submitted an LDT for FDA review would be receiving a letter in the near future to confirm whether their test completed the EUA review process or was included in the submissions that did not reach FDA review completion.

The FDA’s decision to end further EUA reviews for LDTs may result in frustration for laboratories already in the end-stage process of development and close to submission for an LDT EUA review; even more so for lab developers who had already submitted an LDT for review and were not yet issued an FDA determination. The consequence is that LDT developers now have to pursue traditional pre-market approval or 510(k) clearance pathways, or forgo any FDA review altogether.

Foregoing FDA review and bringing an LDT for SARS-CoV-2 diagnosis to market without obtaining FDA premarket approval or an EUA carries implications for which laboratories should be aware. The Public Health and Emergency Preparedness (PREP) Act offers protection that is not otherwise available to clinical labs choosing to develop LDTs without FDA premarket review or an EUA. As relevant to laboratories, the PREP Act’s immunity offers protection from “suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered [device],” for diagnosing the Coronavirus, otherwise known as “COVID-19.”

The American Clinical Laboratory Association (ACLA), a vocal advocate for clinical and diagnostic labs, released a statement following the FDA’s announcement to end LDT EUA reviews, asserting that many of the tests already granted EUAs for COVID-19 have been “innovative, high-throughput LDTs that have reduced reliance on supplies and been integral to expanding testing capacity,” the same types of tests the FDA indicates it seeks to prioritize. ACLA remarked that the FDA’s announcement “creates unnecessary confusion.”

Laboratories interested in participating in the FDA’s weekly Town Hall series for live guidance on SARS-CoV-2 test development can sign up here.

For additional information, please contact the McDonald Hopkins attorneys below:

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