FDA

Our hope is that the critical national shortage of rescue ventilators identified during the COVID-19 pandemic, which exposes a strategic vulnerability; as well as the realization that developing nations have no ventilators at all will find a potential solution in this Field Ventilator device. Through testing and refinement, we hope that this device will provide a real solution that can be readily produced at reasonable cost... The content has not been reviewed or approved by the U.S. Food and Drug Administration (FDA). Interested readers are encouraged to contact the FDA and review available FDA materials, including their guidance on ventilators as well as the Department of Health and Human Services (DHHS) declaration of liability immunity for medical countermeasures against COVID-19.