3D-printing company Formlabs expects its swabs to receive FDA exemption

Formlabs, the
privately held, Massachusetts-based 3D-printing company, will soon
receive an exemption from the U.S. Food and Drug Administration for
its swab designed for use in COVID-19 test kits, TechCrunch has
learned.

Global supply chains for test kit components including swabs and
chemical reagents have hampered the ability of governments to
increase testing to a point where they can adequately ascertain the
scope of the outbreak of the novel coronavirus within their
borders.

“Yesterday we got a notification from the FDA that this is
going to be a class one exempt product,” said Formlabs chief product
officer David Lakatos. “As long as it’s manufactured in an ISO
135 controlled facility.”

As cases are identified across the U.S., tests are flowing to
the geographies where the disease has spread the fastest, leaving
other parts of the country under-resourced to address what could be
an increasing outbreak in other communities that have yet to
receive a complete picture of the disease’s spread.

With swabs, the problem has been compounded that of the few
manufacturers of the sorely needed test kit component, only one is
in the U.S. while another is in Italy.

“About a week and a half ago we joined this effort,” says
Lakatos.

Formlabs is uniquely positioned to scale up production he said,
thanks in part to the 60,000 printers the company has on hand and
the recent acquisition of a facility in Ohio that enables the
company to make surgical-grade products.

The company is currently finishing up human trials and gearing
up to expand capacity at its Ohio manufacturing facility. According
to Lakatos, the company will be able to supply 100,000 swabs per
day. “We are starting to print these,” Lakatos said. “But we
won’t send anything out until we get the green light.”

Currently most of the swabs are earmarked for partner hospitals
that worked with the company to develop the swabs, but the company
is also working with large distributors to access their
distribution channels and get the swabs into roughly 3,000
hospitals around the U.S.

“At the end of the day we’re just looking to get them
out,” Lakatos said.

Source: FS – All Tech News 2
3D-printing company Formlabs expects its swabs to receive FDA exemption