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.
- 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
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|
|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|