The Food and Drug Administration (FDA) has explained the more relaxed rules are because of the current ventilator shortage due to the coronavirus pandemic.
What this announcement means is that the FDA is permitting ventilator manufacturers to modify hardware and software without first submitting a premarket notification. Previously companies would have had to receive a premarket 510(k) notification from the FDA which proved any modifications didn’t create any undue risk.
The FDA said the guidance also offers a streamlined path to market for automakers and other non-medtech manufacturers that want to repurpose their plants to supply ventilators during this crisis.
Alex Azar, Department of Health and Human Services secretary, said in a statement: “The FDA’s new actions will mean America can make more ventilators during this crisis."
Azar continued: “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.”
FDA Commissioner Stephen Hahn commented: “The FDA is doing everything we can to support patients, healthcare 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.
“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.
“We believe this action will immediately increase ventilator availability. We will continue to engage with both traditional medical device manufacturers and other manufacturers about ways we can facilitate a ramping up of production of these life-saving medical devices.”