FDA takes action to increase ventilator availability during the COVID-19 pandemic

The FDA announced on Sunday that it will help increase the availability of ventilators and accessories, along with other respiratory devices, during the COVID-19 pandemic. FDA Commissioner Stephen Hahn remarked that "we are providing maximum regulatory flexibility to facilitate an increase in ventilator inventory, while still providing crucial FDA oversight. We believe this action will immediately increase ventilator availability."

The FDA's guidance outlines the agency's intent to exercise "enforcement discretion" for certain modifications to a ventilator device, such adding wireless and/or Bluetooth capability for remote monitoring. 

Health and Human Services Secretary Alex Azar said that the FDA's actions will mean the US "can make more ventilators during this crisis," adding that "medical device makers can more easily make changes to existing products, such as changes to suppliers or materials, to help address current manufacturing limitations or supply shortages."

 

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