Formlabs received word from the FDA that the company’s 3D-printed swabs meant for COVID-19 test kits may soon receive a class one exemption in a bid to contain the growing pandemic.
According to Formlabs chief product officer David Lakatos, FDA has notified them of the potential exemption as long as the swabs are manufactured in an ISO 135 controlled facility.
Quick update on where we are with COVID-19 response with @formlabs: https://t.co/T4Fx0GHGHd— Dávid Lakatos (@dogichow) March 22, 2020
1) We are waiting for final validation to print swabs for test kits. We can print ~300 per platform and we have in-house ~250 printers in Ohio + 800+ through our volunteer network.
The 3D-printed swabs isn’t the only project the company is working on – it’s also working with design laboratories, doctors, and volunteers to address the crisis, such as designing prototypes for alternative PPEs and ventilation splitters.
“We are working closely with health systems, government agencies, and our network of over 1,500 volunteers to help design, prototype, and produce parts to be tested and potentially adopted by clinicians,” Formlabs stated in its blog.