Home Article FDA extends EUA for vents, other devices

FDA extends EUA for vents, other devices

FDA extends EUA for vents, other devices Agency also publishes final guidance for transition

By HME News Staff

Updated 10:09 AM CDT, Mon March 27, 2023

WASHINGTON – The U.S. Food and Drug Administration has announced in the Federal Register that the Emergency Use Authorization for certain ventilators and PAP and RAD devices will be in effect until Nov. 7, 2023, 180 days beyond the end of the public health emergency on May 11.

The EUA, which was issued under separate authority from the PHE, allows for certain vents, PAP and RAD devices to be used by patients, even though they haven’t gone through the formal FDA clearance process. During the pandemic, the EUA was issued to help address a spike in demand for the devices and ease strains on the supply chain.

After Nov. 7, manufacturers will have to go through certain FDA processes to allow those devices to be used by patients.

The FDA on March 24 published final guidance on those processes:

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).

The FDA’s draft guidance was posted for stakeholder feedback in December 2021.