FDA Template - Supplemental Template for Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing The FDA “Supplemental Template for Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing” provides recommendations for supporting EUA screening claims that rely on repeat testing rather than pre-authorization asymptomatic studies. It specifies expected serial testing intervals, minimum clinical performance thresholds in symptomatic populations, post-authorization study obligations for asymptomatic performance, and labeling requirements for serial, POC, and at-home use. It is used alongside primary molecular or antigen EUA templates to structure submissions and labeling for serial screening programs. primary file regulatory fda-policy 2021-10-25_FDA Template - Supplemental Template for Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing.md regulatory/fda-policy/2021-10-25_FDA Template - Supplemental Template for Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing.md 2021_10_25 docx docx Public Domain 1565 2420 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