The FDA’s Center for Devices & Radiological Health (CDRH) has issued a letter to the medtech industry that outlined the steps it is taking to address the impact of the COVID-19 pandemic.
The administration has already expressed its openness to issuing emergency use authorization (EUA) for ventilator devices amid a shortage in the U.S. Last week, the U.S. Dept. of Health and Human Services (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 (EUA) availability for devices such as previously unapproved ventilators, anesthesia gas machines and positive pressure breathing devices, such as CPAP and BiPAP machines, modified for use as ventilators. The FDA said that manufacturers can submit a request to the agency have products added to the EUA list.
The agency has yet to issue guidance clarifying its stance on makeshift, “DIY”-style ventilators, like the ones engineers at the University of Minnesota have developed, which is touted as a ventilator made from equipment valued at $150. However, CDRH said in its letter that it is strongly encouraging applicants to submit pre-EUAs to discuss technologies that might help address the emergency.
In the letter, FDA said that it has converted in-person meetings with the industry to teleconferences wherever possible, using technology to hold these meetings scheduled through April 30. The administration will assess whether further meetings scheduled for later than April 30 should be converted to teleconferences as well.
CDRH said its document control center still receives and processes incoming documents. For security reasons, it is unable to accept submissions via email, but it is looking into other electronic options. Marketing applications currently on hold as of March 16 have had response due dates for CDRH extended by 60 days for 510(k) clearance, premarket approval, humanitarian device exemption and de novo classification requests. The center intends to extend the due date automatically, so no extension requests are necessary.
