A 3D-printing private company, Formlabs is going to get an exemption for distributing swab designed by them from the U.S. Food and Drug Administration. As a result, these swabs can be used as COVID-19 test kits.
In its specialized guideline introduced to control COVID-19, The US Food and Drug Administration forbade using any kind of test kits manufactured or provided by private companies. In this guideline, the FDA tried to bring more safety equally for health professionals and general people. As test kits provided by private companies do not always maintain standard quality, the FDA imposed a restriction on such products.
Besides, the test kits supply chain has hampered U.S. Govt. to reach a point from where they can assess the COVID-19 outbreak. With spreading coronavirus rapidly, the existing supply test kits are distributed to the most affected locations. Other less affected areas and communities are left in an uncertain risk. Now Govt. needs more test kits that meet standard quality to draw an exact outline of the current situation of these areas.
In a statement, the chief product officer Of Formlabs David Lakatos informed that since Formlabs is manufacturing these swabs in an ISO 135 specialized facility, FDA will exempt its products as a class one product.
Though manufacturing swabs are a recent venture for Formlabs, 60,000 printers and the facility in Ohio allow it to produce products of surgical grade.
Formlabs has already done with its testing and trialing phase and now its planning on supply roughly 100,000 swabs every day.