FDA Guidance - Transition Plan for Medical Devices Issued EUAs The FDA “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to COVID-19” (March 27, 2023) describes how manufacturers should transition devices from EUA status to normal regulatory pathways after EUA declarations are terminated. It outlines expectations for marketing submissions, continued or discontinued distribution, labeling updates, and disposition of already distributed devices, with special provisions for in vitro diagnostics, CLIA categorization, and life-supporting or reusable equipment. primary file regulatory fda-policy 2023-03-27_FDA Guidance - Transition Plan for Medical Devices Issued EUAs.md regulatory/fda-policy/2023-03-27_FDA Guidance - Transition Plan for Medical Devices Issued EUAs.md 2023_03_27 pdf Public Domain 9094 12172 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