Emergency Use Authorization for Ventilators and Related Equipment

In response to the growing ventilator shortage caused by COVID-19, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) encompassing ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories (see 21 CFR 868). Product manufacturers that seek to be included in the EUA must submit a request to FDA and obtain approval prior to distribution. The ventilators, ventilator tubing connectors, and ventilator accessories that are eligible for inclusion under the EUA are:

1. Those that are not currently marketed in the U.S., or 
2. 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 FDA.

In its Enforcement Policy Final Guidance, FDA recommends the steps manufacturers should take to make their product available domestically. For ventilators that are currently not marketed in the US, these steps include providing FDA with information regarding whether the device is currently authorized by another regulatory jurisdiction and whether the device has been appropriately evaluated and validated according to FDA recognized standards. FDA states that it will acknowledge receipt of such information, and intends to “work interactively” with these manufacturers in order to facilitate the distribution of their products under the EUA. However, for companies that have not previously been involved in making medical devices but have the interest and capability to manufacture them, FDA states that it “welcomes the opportunity to work with [these] manufacturers” and “intends to work collaboratively” with them through the EUA process. 

Also in its Final Guidance, FDA states that it “does not intend to object to limited modifications to the indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices.” The Agency requires devices be adequately labeled to give users a clear description of the modifications made as well as instructions for use. Manufacturers must clearly distinguish FDA-cleared indications and claims from those that are not FDA-cleared but are authorized pursuant to the EUA. Manufacturers are encouraged to reach out to FDA to engage in a pre-EUA meeting. In doing so, the manufacturer will be able to provide the Agency with all necessary information to more readily bring its product to the market. 

This regulatory flexibility has been authorized to address the observed and anticipated shortages of ventilators, ventilator tubing connectors, and ventilator accessories. To further incentivize the rapid manufacture and distribution of these products, products approved in EUAs may be considered “Covered Countermeasures” against COVID-19 and thus eligible for protections under the Public Readiness and Emergency Preparedness Act (PREP Act). The PREP Act provides that manufacturers and distributors of qualifying Covered Countermeasures cannot be held liable for claims of loss directly associated with use of their products. It is hoped that these efforts will facilitate an influx of much-needed ventilators to the U.S. healthcare system.