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FloodLAMP FDA Correspondence - Deprioritization EUA210252 EUA210254 The April 2, 2021 FDA email and attached deprioritization letter notify FloodLAMP that EUA210252 (QuickColor COVID-19 Test) was closed because FDA declined to review it under then-current prioritization criteria. It explains that, in a later phase of the pandemic with many tests already authorized, FDA prioritized requests expected to materially increase U.S. testing accessibility (e.g., POC, home collection, at-home) or capacity (e.g., high-throughput), and judged FloodLAMP’s submission as having relatively limited impact on those factors. The document also notes the same decision and attachment were issued for a related EUA request (EUA210254). primary file regulatory fl-fda-correspondence 2021-04-02_FloodLAMP FDA Correspondence - Deprioritization EUA210252 EUA210254.md regulatory/fl-fda-correspondence/2021-04-02_FloodLAMP FDA Correspondence - Deprioritization EUA210252 EUA210254.md 2021_04_02 gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 675 1309 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
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