Tag: Emergency Use Authorization
FDA extends EUA for vents, other devices
March 27, 2023HME News Staff
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....
