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).
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2021-04-02_FloodLAMP FDA Correspondence - Deprioritization EUA210252 EUA210254.md
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2021_04_02
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