March 10, 2023 Update: The FDA divided into two the guidance, Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised). The two new guidances have no changes to the enforcement policy:

• Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency
• Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency

This division of the previous version of the guidance does not affect the current policy and is intended only to facilitate a different timeline and process for transitioning back to normal operations, as further described in the Federal Register notice on this topic and on the COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders web page.

All written comments on these two guidances should be identified with this docket number: FDA-2020-D-1138.

March 24, 2023 - The FDA has 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). The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for:

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

The FDA encourages stakeholders to review the two final guidances, attend the webinar, and reach out to the FDA if they have questions or concerns. In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.

Additional Resources:

• Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
• Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
• Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023