The Commissioner of the Food and Drug Administration says the agency has taken action to increase the supply of ventilators, ventilator tubing connectors, ventilator accessories and filtering facepiece respirators. Commissioner Dr. Stephen Hahn issued a statement that the FDA has signed off on an Emergency Use Authorization (EUA) to ease the pressure on the health care system during the COVID-19 pandemic.
The statement says the EUA "allows for emergency use in health care settings of certain ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices... that the FDA determines meet specified criteria.."
It all means there is regulator flexibility, according to the statement, to increase the number of ventilators available to the very ill in the U-S while still exercising FDA oversight of the equipment. Those include diagnostic and therapeutic medical devices that can be used to respond to the public health crisis.
The FDA statement indicates that the EUA does not mean general public use of authorized respirators is permitted.