The Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as ventilators), ventilator tubing connectors, and ventilator accessories that the FDA determines meet specified criteria for safety, performance and labeling on March 24, 2020.
Ventilator tubing connections will allow for single ventilators to be used for multiple patients simultaneously. The EUA applies to ventilators, ventilator tubing connectors, and ventilator accessories that are not currently marketed in the U.S. or that are currently marketed in the U.S. but a modification to the device would require a new premarket 510(k) notification as set forth in the guidance, “Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” Authorized devices are added to Appendix B of the EUA.
In order for ventilators, ventilator tubing connectors and ventilator accessories to be used according to the EUA, the devices must meet the safety, performance and labeling set forth in Appendix A of EUA. FDA will add a device to the EUA upon request by the sponsor and after confirming the device meets the safety, performance and labeling standards of the EUA. After authorization, the sponsor must label the device with information specified in Appendix A, which includes fact sheets for health care providers and patients.
FDA waived Current Good Manufacturing Practice (CGMP) requirements (see 21 CFR Part 820) regarding the "design, manufacture, packaging, labeling, storage, and distribution" of devices authorized under the EUA. In addition, registration and listing requirements have been waived (see 21 CFR Part 807).
Sponsors will need an adverse event reporting system and to maintain records of where the EUA devices are distributed. If sponsors choose to promote EUA devices, the promotional material must include statements that the device has not been FDA cleared or approved, the device has been authorized by FDA under an EUA, and the device is authorized only for the duration of the circumstances justifying its emergency use. Readers interested in the details of each section should refer to the EUA; an incomplete summary of the contents is provided here.
As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.