FDA hosts town hall for labs certified for high-complexity testing

March 5, 2020

The Food and Drug Administration (FDA) will host a town hall about a recently issued guidance that allows high complexity labs to use validated COVID-19 diagnostics before the FDA has completed a review of their Emergency Use Authorization (EUA) requests.

The virtual town hall is scheduled for Friday, March 6, 2020, beginning at 1 p.m. (EST).

The policy only applies to laboratories that are certified to perform high-complexity testing, consistent with the requirements of the Clinical Laboratory Improvement Amendments.

The new guidance describes the circumstances where the FDA does not intend to object to the use of these tests for clinical testing while the laboratories are pursuing an EUA with the FDA. It also provides recommendations for test developers, including information regarding test validation, FDA notification and interim confirmatory clinical testing.

At the town hall, FDA officials will answer technical questions about both the development and validation of molecular tests for the novel coronavirus and the recently issued guidance.

Questions about the town hall should be directed to the FDA’s Division of Industry and Consumer Education.

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