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FDA Advances Serological Test Validation, Educational Efforts During COVID-19 Pandemic

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The FDA has announced that the administration will expand access to serology tests and its approach to making accurate and reliable serology tests widely available, while also protecting Americans from tests marketed with false or unsubstantiated claims, the FDA announced on Saturday.

The administration will continue to provide developers with a request for FDA authorization through the emergency use authorization (EUA) process. The FDA has already issued four EUAs for serological tests, and expect that number to continue to grow in the coming weeks.

The FDA will encourage developers to submit EUA requests for their tests, as an EUA will provide laboratories and providers with assurance that FDA has reviewed that test. The administration will quickly review EUA submissions and continue to take steps to ensure the process is as streamlined and efficient as possible.

To enhance the U.S. Government’s ability to identify well-performing tests and inform FDA recommendations and decision making, the administration will collaborate with the National Institutes of Health’s National Cancer Institute (NCI) and National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention (CDC).

Under the partnerships, the agencies will be able to establish a capability at NIH to evaluate serological tests for developers. The effort will include tests already available for use, as well as tests not yet on the market where additional validation data is needed to support an EUA.

In addition, the FDA has projected performance assessments for serological tests will begin soon, and the administration has expected results shortly thereafter. The administration will review NIH’s results expeditiously, and performance results from NIH’s assessment may complement and inform the determination of whether FDA issues an EUA for a particular test.

About FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.