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  6. COVID-19 Emergency Use Authorizations for Medical Devices
  7. Other Medical Device EUAs
  1. COVID-19 Emergency Use Authorizations for Medical Devices

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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.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

 

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