FDA Issues Final Guidances for COVID-19 Medical Device Transition Plans

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March 25, 2023, the U.S. Food and Drug Administration finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19).

These guidances outline the FDA’s general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations. The recommendations include information for devices that fall within certain enforcement policies issued during the COVID-19 public health emergency (PHE) under section 319 of the Public Health Service Act and devices issued EUAs related to COVID-19 under section 564 of the Federal Food, Drug, and Cosmetic Act, including:

  • Developing a transition implementation plan,
  • Submitting a marketing submission, and
  • Taking other actions with respect to these devices.

There will be a 180-day transition period for impacted devices to help avoid disruption in device supply and help ensure an orderly and transparent transition (specific information on the scope and the timeline for the transition period can be found in each guidance).

Please contact RQMIS to help you with your transition planning

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