Formlabs, a 3D-printing firm based in Massachusetts, will be securing an exemption from the U.S. Food and Drug Administration for the swab designed by the firm to be used in COVID-19 test kits.
Apparently, the supply chains for the test kit components across the world, that also include chemical reagents and swabs, have hampered the ability of global governments to expand testing enough to sufficiently determine the scope of the outbreak of coronavirus within their borders.
David Lakatos, the chief product officer at Formlabs, said that the company had received a notification from the FDA stating that the swab will be considered as class one exempt product as long as it shall be produced in a facility that is ISO 135.
Tests for coronavirus have been transported to certain geographical areas that have been massively hit by the disease, as cases are still being recognized in the U.S. Some parts of the country that are under-resourced have seemingly been ignored to address a possible increase in the outbreak across communities that have not yet experienced the spread of the disease entirely.
According to reliable sources, production and supply of swabs is a critical component of the world’s efforts to counter the COVID-19 risk, as a time when manufacturers needed test kit components.
Lakatos added that Formlabs has been positioned to ramp up the production. With the help of its recent acquisition of a facility located in Ohio as well as the significant number of printers Formlabs possesses, it has been able to develop surgical-grade products.
Formlabs is completing its human trials and getting ready for the expansion of capacity at the manufacturing facility in Ohio. As per Lakatos’s statement, the company will be supplying about 100,000 swabs every day. The swabs have already started being printed but the company does not plan to send anything out until they are permitted to.