Amid a shortage of ventilators for treating coronavirus, the FDA put out a statement confirming its stance on issuing emergency use authorizations for potential temporary fixes.
The FDA said it is operating on the basis of a EUA determination that the U.S. Dept. of Health and Human Services issues on Feb. 4. Earlier this week, HHS declared that circumstances exist that justify the authorization of emergency use of medical devices during the COVID-19 pandemic.
That HHS declaration includes emergency use authorization availability for devices such as previously unapproved ventilators, anesthesia gas machines modified for use as ventilators and positive pressure breathing devices modified for use as ventilators. FDA said that manufacturers can submit a request to the agency in order to have products added to the EUA.
With the growing need for such devices and the availability of EUA, some research teams took it upon themselves to develop makeshift, “DIY”-style ventilators, such as engineers at the University of Minnesota, who are touting a ventilator made from equipment valued at $150.
However, while the FDA guidance on EUA includes alternative products used as medical devices, there is no clear stance on whether devices like the Minnesota team’s “Coventor” could potentially garner authorization.
MassDevice has reached out to FDA for comment but has not received a response. This story may be updated.