FDA Website - Pooling and Serial Testing Amendment The Pooling and Serial Testing Amendment explains FDA’s April 20, 2021 amendment that allowed certain authorized molecular SARS-CoV-2 tests to use pooled anterior nasal specimens from asymptomatic individuals within serial testing programs after developers submit a complete notification and validation documentation. It specifies CLIA high-complexity laboratory limitations and describes how authorized pooling parameters vary by appendix (pool sizes up to 3, 5, or 10 and media vs. swab pooling). It also clarifies that FDA adding a test to the exhibit/list reflects receipt of required documentation and does not necessarily indicate FDA review of the underlying validation data. primary file regulatory fda-policy 2021-04-20_FDA Website - Pooling and Serial Testing Amendment.md regulatory/fda-policy/2021-04-20_FDA Website - Pooling and Serial Testing Amendment.md 2021_04_20 date converted 2024-03-27 website Public Domain 298 404 gfile-url xfile-github-download-url pdf-gdrive-url pdf-github-url github-markdown-url github-markdown-download-url web-pdf-url web-slides-url youtube-url web-url