Memo - Surveillance Authority Plain-language Research (Jan 2021 from Senior Medical Director in Healthcare Industry) The plain-language CMS/FDA overview summarizes how “surveillance” COVID-19 testing is described in FDA guidance as population-level monitoring that FDA generally does not regulate, and explains conditions under which individual results may be returned if presumptive positives are routed to confirmatory testing in a CLIA-certified laboratory. It also cites CMS’s temporary enforcement discretion under CLIA for certain SARS-CoV-2 surveillance testing workflows, especially where non-CLIA facilities do not report definitive results but instead refer presumptive positives or inconclusives to a CLIA lab. It frames these points as a non-legal explanatory digest of agency guidance and notes that public health authorities may have additional powers to support population safety efforts. primary file regulatory surveillance Memo - Surveillance Authority Plain-language Research (Jan 2021 from Senior Medical Director in Healthcare Industry).md regulatory/surveillance/Memo - Surveillance Authority Plain-language Research (Jan 2021 from Senior Medical Director in Healthcare Industry).md 2021_01_11 pdf 3rd Party 447 713 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