FDA Website - In Vitro Diagnostics EUAs The In Vitro Diagnostics EUAs page explains FDA’s COVID-19 IVD EUA framework after the May 11, 2023 expiration of the HHS public health emergency and the end of certain COVID-19 enforcement-policy guidances. It clarifies that the PHE’s end did not eliminate FDA’s authority to keep existing EUAs in effect or issue EUAs under FD&C Act section 564, and it directs manufacturers to FDA’s EUA transition-plan guidance and related FAQs for expectations when EUA declarations eventually end. primary file regulatory fda-policy 2023-11-08_FDA Website - In Vitro Diagnostics EUAs.md regulatory/fda-policy/2023-11-08_FDA Website - In Vitro Diagnostics EUAs.md 2023_11_08 date converted 2024-04-05 website Public Domain 217 507 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