U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Medical Device Safety
  4. Emergency Situations (Medical Devices)
  5. Emergency Use Authorizations for Medical Devices
  6. COVID-19 Emergency Use Authorizations for Medical Devices
  7. Respiratory Assist Devices EUAs
  1. COVID-19 Emergency Use Authorizations for Medical Devices

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Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (see List 1) are no longer in effect.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

Respiratory assist devices include devices intended to help patients in need of support for breathing, removal of carbon dioxide, and therapy to reduce disuse atrophy of abdominal wall muscles. The FDA has issued EUAs to help increase the availability of respiratory assist devices, which are integral to treat patients during the COVID-19 pandemic.

The table below lists the respiratory assist devices authorized for use during the COVID-19 public health emergency.

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
04/13/2020 Diaphragmatic Pacing Therapy System (DPTS) Synapse Biomedical, Inc. TransAeris Diaphragmatic Pacing Therapy System (DPTS) QPR
4/14/2020 Diaphragmatic Pacing Therapy System (DPTS)

Lungpacer Medical, Inc. Diaphragm Pacing Therapy System (DPTS)

 QPR
04/22/2020 Respiratory Assist Device ALung Technologies, Inc., Hemolung RAS QLN
05/01/2020 Respiratory Muscle Stimulator Liberate Medical, LLC VentFree Respiratory Muscle Stimulator Device QPR
07/10/2020 non-Invasive Vagus Nerve Stimulator electroCore, Inc., gammaCore Sapphire CV QPR
06/30/2021 Incentive Spirometer Accessory Tidal Medical Technologies LLC, InSee QOO

 

Back to Top