March 2, 2020

FDA Issues Guidance for Diagnostic Testing Applicable to Coronavirus Disease

Holland & Knight Healthcare Blog
Michael J. Werner | Sara M. Klock
Healthcare Blog

The U.S. Food and Drug Administration (FDA) has issued a new guidance for novel coronavirus (COVID-19) molecular diagnostics tests developed and used in certain laboratories. The guidance, issued on Feb. 29, 2020, is designed to facilitate access to such tests to more quickly identify respiratory disease caused by the " 'SARS-CoV2' virus that has led to the outbreak worldwide of Coronavirus Disease 2019" (COVID-19).

The new policy applies to certain laboratories that develop and begin to use validated COVID-19 diagnostics before the FDA has completed review of their Emergency Use Authorization (EUA) requests.

Under current law, the FDA can issue an EUA to allow otherwise unapproved medical products or unapproved uses of products in certain emergency circumstances after the Secretary of the U.S. Department of Health and Human Services (HHS) has made a declaration of emergency or threat justifying authorization of emergency use to diagnose, treat, or prevent serious or life-threatening disease or conditions caused by chemical, biological, radiological and nuclear (CBRN) threat agents when certain criteria are met.

HHS Secretary Alex Azar on Feb. 4, 2020, determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus.

So far, the FDA has granted an EUA to two public health laboratories in New York for a diagnostic test to identify COVID-19 and one authorized EUA for COVID-19 that is in use by the U.S. Centers for Disease Control and Prevention (CDC) and some public health labs across the country.

The guidance enables labs to immediately use tests they developed and validated. It requires that the tests must be developed and used in laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA). The guidance describes in more detail the other circumstances where FDA will not object to the use of these tests while the laboratories are pursuing an EUA.

Specifically, the FDA guidance provides recommendations for test developers, including information regarding test validation and interim confirmatory clinical testing. In addition, the guidance requires notification to FDA following completion of assay validation. FDA recommends that laboratories submit a completed EUA request within 15 business days of the initial communication to FDA that the assay has been successfully validated.
FDA also recommends that test reports include a general statement that the test has been validated but FDA's independent review of this validation is pending.

Laboratories are required to immediately notify appropriate federal, state or local public health agencies of all positive results.

Other announcements and policy changes from FDA with respect to COVID-19 are anticipated in the coming weeks and months.

Please let us know if you have any questions about this new guidance or other FDA policies in relation to the coronavirus.

DISCLAIMER: Please note that the situation surrounding COVID-19 is evolving and that the subject matter discussed in these publications may change on a daily basis. Please contact the author or your responsible Holland & Knight lawyer for timely advice.

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