The Food and Drug Administration (FDA) has added a ventilator developed by the National Aeronautics and Space Administration (NASA) to the COVID-19 ventilator emergency use authorization (EUA).
The EUA authority allows the FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear threats by facilitating the availability and use of medical countermeasures needed during public health emergencies. Medical countermeasures are medical products such as drugs, vaccines, diagnostic tests, and other medical equipment and supplies needed to respond to emergencies involving such threats. In some cases, medical countermeasures might already be approved and will be used in approved ways during a response. In other cases, the best medical products available for a response might be unapproved or need to be used in unapproved ways.
The FDA included the NASA VITAL (Ventilator Intervention Technology Accessible Locally) under the ventilator EUA. The VITAL ventilator is intended to provide continuous ventilatory support for adults (body weight ≥ 50 kg) who require mechanical ventilation. The VITAL ventilator provides patients with emergency ventilatory support when no alternative standard ventilators are available.
The VITAL ventilator is intended to last 3 to 4 months and is specifically tailored for patients with COVID-19. 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. This medical device does not replace current hospital ventilators, which can last for years and are built to address a broader range of medical issues.
Food and Drug Administration (FDA). Coronavirus (COVID-19) Update: FDA Includes Ventilator Developed by NASA in Ventilator Emergency Use Authorization. April 30, 2020. Available at: click here. Accessed April 30, 2020.