FDA Letter - Repeat Testing Revision Letter
The FDA “Repeat Testing Revision Letter” (November 1, 2022) revises all EUA-authorized SARS-CoV-2 antigen tests to require updated serial testing frequencies based on new clinical evidence. It mandates labeling changes specifying at least two tests over three days for symptomatic individuals and at least three tests over five days for asymptomatic individuals, while removing prior post-authorization study requirements. It standardizes consumer, healthcare provider, and digital app instructions to emphasize that negative antigen results are presumptive and that repeat testing is essential for accuracy.
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2022-11-01_FDA Letter - Repeat Testing Revision Letter.md
regulatory/fda-policy/2022-11-01_FDA Letter - Repeat Testing Revision Letter.md
2022_11_01
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