FDA Warning Emails to FloodLAMP - Re_ Testing Clinical COVID-19 Samples (March 2022) The FDA–FloodLAMP email thread (Jan–Mar 2022) documents FDA outreach after reviewing FloodLAMP’s website, requesting clarification on whether FloodLAMP was offering clinical COVID-19 testing, whether it held a CLIA certificate, and whether the method was EUA-authorized. FDA flagged website language suggesting individual follow-up testing with FloodLAMP after a positive pool as inconsistent with “surveillance” testing, and asked FloodLAMP to remove or revise claims and confirm plans to bring the site into compliance. The exchange ends with FloodLAMP stating it removed the individual follow-up FAQ language and FDA reiterating that FloodLAMP should review and align practices with the FDA’s revised COVID-19 testing policy guidance and that agency priorities may change. primary file regulatory surveillance FDA Warning Emails to FloodLAMP - Re_ Testing Clinical COVID-19 Samples (March 2022).md regulatory/surveillance/FDA Warning Emails to FloodLAMP - Re_ Testing Clinical COVID-19 Samples (March 2022).md 2022_03_01 Title says March 2022, so used 2022-03-01 as date. pdf CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 1568 2268 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