Small Tweaks to Ventilators Allowed to Boost Supply, FDA Says

Ventilator manufacturers are free to modify devices that have already been approved by the FDA in order to boost supply of the machines to combat the coronavirus outbreak.

The Food and Drug Administration issued new guidance Sunday that allows limited modifications of previously approved models of ventilators, anesthesia gas machines, and other respiratory devices without worrying about federal enforcement.

The agency still recommends using conventional respirators whenever possible to treat patients suffering from Covid-19, the disease caused by the coronavirus.

“We believe this approach will help manufacturers that want to add production lines or manufacture at alternative sites which may have different manufacturing equipment to increase manufacturing capacity and supply and reduce supply change interruptions and manufacturing bottlenecks,” the agency said.

The policy will remain in effect for the duration of the outbreak.