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
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)||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|