Memo - USA Surveillance Strategy (Sept 2021 from non-FloodLAMP Healthcare Attorney)
The follow-up email summarizes guidance that COVID-19 surveillance testing is generally not regulated by FDA or CLIA when samples lack unique identifiers and no individual results are returned, citing FDA and CDC language. It recommends coordinating with local public health officials, structuring groups large enough to support anonymized aggregate reporting, and ensuring testing is administered by appropriately trained personnel consistent with state law.
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Memo - USA Surveillance Strategy (Sept 2021 from non-FloodLAMP Healthcare Attorney).md
regulatory/surveillance/Memo - USA Surveillance Strategy (Sept 2021 from non-FloodLAMP Healthcare Attorney).md
2021_09_01
docx
docx
CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
593
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