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  1. COVID-19 Emergency Use Authorizations for Medical Devices

Other Medical Device EUAs

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:

This page lists EUAs not described in any of the other pages in the Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices Section.

Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.

Date EUA Issued Device Type Letter of Authorization Fact Sheets Other Documents Assigned Product Code
03/15/2023 LVEF Screen Anumana Inc, ELEFT QLL
05/26/2020 Predictive Screening CLEW Medical Ltd. QLM
05/29/2020 Right Ventricular Assist Catheter Abiomed, Inc., Impella RP System QOC
04/18/2020 Face Mask (non-Surgical) Face Mask (non-Surgical)   QKR
08/03/2020 Left Ventricular Support System Abiomed, Inc., Impella LV Systems QOC
09/24/2020 Predictive Screening COVIage QLM
11/21/2020 Extracorporeal Membrane Oxygenation Terumo Cardiovascular CAPIOX Emergency Bypass System QOD
03/19/2021 Symptom Screening Tool Tiger Tech Solutions, Inc., Tiger Tech COVID Plus Monitor QOA


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