From: Food And Drug Administration (FDA)
Posted: Thursday, April 30, 2020
The U.S. Food and Drug Administration included, under the ventilator emergency use authorization (EUA), a ventilator developed by the National Aeronautics and Space Administration (NASA), which is tailored to treat patients with COVID-19. The ventilator was added to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator EUA that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic.
"Fighting the virus and treating patients during this unprecedented global pandemic requires innovative approaches and action. It also takes an all hands-on deck approach, as demonstrated by the NASA engineers who used their expertise in spacecraft to design a ventilator tailored for very ill coronavirus patients. This example shows what we can do when everyone works together to fight COVID-19," said FDA Commissioner Stephen M. Hahn, M.D. "We believe today's action will increase availability of these life-saving medical devices. The FDA will continue to add products to this emergency use authorization, as appropriate, during this pandemic to facilitate an increase in ventilator inventory."
The FDA included the NASA VITAL (Ventilator Intervention Technology Accessible Locally) under the ventilator EUA. VITAL is intended to last three to four months and is specifically tailored for patients with COVID-19, by providing respiratory support for patients that are experiencing respiratory failure or insufficiency. The device is designed to be built with components outside the current medical device supply chain and therefore does not impact the existing supply chain of currently made ventilators. Like all ventilators, VITAL requires patients to be sedated and an oxygen tube inserted into their airway to breathe. This medical device does not replace current hospital ventilators, which can last years and are built to address a broader range of medical issues.
"This FDA authorization is a key milestone in a process that exemplifies the best of what government can do in a time of crisis," said NASA Administrator Jim Bridenstine. "This ventilator is one of countless examples of how taxpayer investments in space exploration – the skills, expertise and knowledge collected over decades of pushing boundaries and achieving firsts for humanity – translate into advancements that improve life on Earth."
The FDA continues to engage with both traditional medical device manufacturers and other stakeholders about ways we can facilitate a ramping up of production of ventilators. On March 24, 2020, the FDA issued its ventilator EUA to allow, for the duration of this pandemic, for the emergency use in health care settings of certain ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories that the FDA determines meet specified criteria for safety, performance and labeling. The devices that are eligible for inclusion under the EUA are those that are not currently marketed in the U.S., or those that are currently marketed in the U.S. but a modification is made to the device that would trigger the requirement that a manufacturer submit a new premarket notification (510(k)) to the FDA, as discussed in the agency's Ventilator Enforcement Policy.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
// end //