FDA Website - Antigen EUA Revisions for Serial Repeat Testing
The Antigen EUA Revisions for Serial Repeat Testing summarizes FDA’s November 1, 2022 revision updating authorized uses and labeling for all authorized SARS-CoV-2 antigen tests to emphasize repeat testing after a negative result. It sets new serial-testing instructions—at least twice over three days for symptomatic use and at least three times over five days for asymptomatic use, with 48 hours between tests—and requires EUA holders to submit supplemental requests with updated labeling. The revision also adds one new Condition of Authorization and removes one that FDA determined was no longer needed.
primary
file
regulatory
fda-policy
2022-11-01_FDA Website - Antigen EUA Revisions for Serial Repeat Testing.md
regulatory/fda-policy/2022-11-01_FDA Website - Antigen EUA Revisions for Serial Repeat Testing.md
2022_11_01
date converted 2024-04-05
website
Public Domain
265
394
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