FDA Letter - Amendment Letter The FDA “Amendment Letter” (April 20, 2021) authorizes certain EUA RT-PCR molecular tests to add screening indications using pooled anterior nasal specimens when deployed in serial testing programs (typically at least weekly), with appendices specifying pooling type (swab vs. media) and maximum pool sizes (e.g., up to 3, 5, or 10). It defines eligibility criteria for which EUAs can be amended, the required validation/notification package for inclusion on FDA’s Exhibit 1 list, and detailed conditions for developers and CLIA high-complexity laboratories (including follow-up for positive/invalid pools, reporting language, and positivity-rate monitoring). It also prescribes required updates to provider and patient fact sheets to address presumptive positives from pools and the limitations of negative results in asymptomatic and pooled testing. primary file regulatory fda-policy 2021-04-20_FDA Letter - Amendment Letter.md regulatory/fda-policy/2021-04-20_FDA Letter - Amendment Letter.md 2021_04_20 pdf Public Domain 8628 10719 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