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# FDA Eases Pooled Serial Screening Claims for Covid Tests
- URL: https://www.fdaweb.com/fda-eases-pooled-serial-screening-claims-for-covid-tests/
- Published: 2021-04-20T12:00:00.000Z
- Updated: 2026-09-14T16:55:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149151

CDRH director **Jeffrey Shuren** [says](https://www.fda.gov/news-events/press-announcements/fda-announces-new-streamlined-approach-add-pooled-serial-screening-claims-certain-authorized-tests?ref=fdaweb.com) FDA has issued an amendment for many molecular diagnostic Covid-19 tests that had received an emergency use authorization. Under the [amendment](https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2?ref=fdaweb.com#amendment), if a test developer has self-certified it has validated its test for pooling, FDA will add that test to a list of tests that can be used for pooling nasal specimens as part of a serial testing program.

“The flexibility that FDA has provided developers continues to be a hallmark of our approach to the Covid-19 pandemic and we will continue to prioritize authorization of tests with the ability to increase testing accessibility or to significantly increase testing capacity,” Shuren says.