Today, the U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing.
“The FDA’s new actions will mean America can make more ventilators during this crisis,” said Health and Human Services Secretary Alex Azar.
“Today’s actions are another step by the FDA and HHS to eliminate every possible barrier to the all-of-America approach that President Trump has called for.
With this boost from the FDA, 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.
Other manufacturers, such as auto makers, can more easily repurpose production lines to help increase supply. Hospitals and other health care providers can repurpose machines they have now to serve as ventilators. HHS and FDA’s message is clear:
If you want to help expand production of ventilators to save American lives in this pandemic, we are going to work with you to sweep every possible barrier out of your way.”
“The FDA is doing everything we can to support patients, health care professionals, hospitals, medical product manufacturers and the public during this pandemic.
One of the most impactful steps we can take is to help with access and availability to life-saving medical treatments,” said FDA Commissioner Stephen Hahn, M.D.
“Our policy issued today demonstrates our ability to react and adapt quickly during this pandemic and help very ill patients access the lifesaving ventilator support they need.
To do that, we are providing maximum regulatory flexibility to facilitate an increase in ventilator inventory, while still providing crucial FDA oversight.