FDA Guidance - Transition Plan for Medical Devices That Fall Within Enforcement Policies The FDA “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency” (March 27, 2023) lays out a phased, 180-day wind-down for devices that were marketed under COVID-era enforcement discretion guidance. It specifies Phase 1–3 compliance expectations (e.g., MDR reporting, corrections/removals, registration/listing), when marketing submissions should be submitted and accepted to keep distributing after the policies end, and when FDA may continue enforcement discretion while a submission is under review. It also includes Notification of Intent requests for certain reusable life-supporting/sustaining devices and recommends a Transition Implementation Plan to manage already-distributed products under both positive and negative FDA decisions. primary file regulatory fda-policy 2023-03-27_FDA Guidance - Transition Plan for Medical Devices That Fall Within Enforcement Policies.md regulatory/fda-policy/2023-03-27_FDA Guidance - Transition Plan for Medical Devices That Fall Within Enforcement Policies.md 2023_03_27 pdf Public Domain 11372 17421 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