The U.S. FDA has taken steps to 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. “These 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 guidance outlines several key steps.

The agency encourages manufacturers, whether foreign or domestic, to talk to FDA about pursuing an emergency use authorization (EUA), which would allow them to distribute their ventilators in the U.S. This includes U.S.-based manufacturers that were previously engaged in making medical devices, but which have capabilities to increase supply of these devices.