Bloomberg Law References Gunawardhana for FDA Perspective on N95 Masks From 3D Printer

Shook Of Counsel Sonali Gunawardhana was sourced by Bloomberg Law on FDA’s criteria for granting COVID-19 new medical device approvals. In the article, “Oregon Printer Takes on Washington to Make N95 Masks,” Gunawardhana, a former FDA attorney with nearly a decade at the agency, gives her insight on the need for considering both quality and speed in the approval-granting process. 

“If they can get to something that they feel has a pretty good safety profile that they’re comfortable with, they’re going to grant the authorization,” Gunawardhana said. “If they feel that the safety profile is too slippery and it could do more damage, they’re not going to give it.”

The article reports on D-6 Inc., a company with the nation’s largest 3D printer, and its effort to get federal regulatory approvals to mass produce N95 respirator masks for the demand generated by the coronavirus pandemic. With approval, D-6 could produce 7.2 million masks daily.