Other Medical Device EUAs
November 8, 2023 - The COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired on May 11, 2023. The COVID-19 enforcement policy guidances within scope of the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.
The end of the COVID-19 PHE and certain COVID-19 enforcement policy guidances no longer being in effect do not impact the FDA's ability to authorize devices, including tests, for emergency use. Existing emergency use authorizations (EUAs) for devices relating to COVID-19 remain in effect under section 564 of the Federal Food, Drug, and Cosmetic Act. The FDA encourages manufacturers of devices issued EUAs related to COVID-19 to review the guidance: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19), which outlines the FDA's recommendations and expectations to such manufacturers to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end. Additional information is provided on the page FAQs: What happens to EUAs when a public health emergency ends?
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 |