Tag: Emergency Use Authorization (EUA)
HHS moves to end pandemic-era emergency use authorization
July 13, 2026HME News Staff
WASHINGTON – The U.S. Department of Health and Human Services has signed determinations terminating the COVID-19 Emergency Use Authorization (EUA) declarations for drugs and biological products and for medical devices. “Americans deserve a regulatory system that is transparent, accountable, and rooted in the rule of law,” said HHS Secretary Robert F. Kennedy, Jr. “By ending these COVID-19 emergency use authorization declarations, we're reinforcing public confidence that...
In brief: MSC and Trace Medical make buys, FDA extends EUA
March 31, 2023HME News Staff
CLEVELAND – Medical Service Company has acquired OhioHealth Home Medical Equipment in Central Ohio.
“Through its three community locations and several in-hospital offices and liaisons, OhioHealth HME supports lightning-fast discharges for the OhioHealth hospital network,” MSC stated in a press release.
MSC has also entered a long-term partnership with the OhioHealth health system, which comprises a family of 35,000 associates, physicians and volunteers, and a network...
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....