FDA No Longer Accepting Applications for Non-NIOSH Approved Respirator Masks Manufactured in China

In a sign that N95 Masks / Respirators are now being supplied in the US at a sufficient quantity to meet demand during the continued COVID-19 Pandemic, the US FDA is currently no longer accepting new Emergency Use Authorization (EUA) submissions for Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China (i.e. KN95) due to the Chinese Standard KN95 mask design having limited adoption in health care settings; also hearing directly from KN95 distributors that imported, non-NIOSH-N95 approved product from China is sitting in US warehouses unused; and hearing from manufacturers that NIOSH-approved N95 production is increasing. Additionally, however, CDC/NIOSH continues to issue more N95 approvals, thus eliminating the need for more Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China that do not have N95 approval. See link below for full details. #FDA #EUA #COVID19 #masks #N95 #respirators #medicaldevices #meddevice #medtech #ppeshortage #NIOSH #China #chinamanufacturing #N95mask #regulatoryaffairs #regulatory #usfda #CDC #emergencyuse #supply #demand https://www.fda.gov/news-events/press-announcements/fda-reissues-emergency-use-authorization-certain-non-niosh-approved-filtering-face-piece-respirators?utm_medium=email&utm_source=govdelivery