N95 respirator face masks removed from FDA’s medical device shortage list – PennLive

N95 respirator face masks have been removed from the FDA’s medical device shortage list as of today.

The U.S. Food and Drug Administration said the move was made because “demand or projected demand for this type of face protection device commonly used in health care settings no longer exceeds the supply.”

The FDA said there are enough N95 masks available because of of increased manufacturing in the United States, information the agency has from “industry and federal stakeholders, and the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health’s (NIOSH) approval of new disposable N95s and reusable respirators.”

An N95 respirator is a protective mask that has a tight fit and highly efficient filtration of airborne particles. The edges form a seal around the nose and mouth.

N95 respirator face masks, especially those used by health care workers, have been in short supply and high demand since the onset of the COVID-19 pandemic in March 2020. The FDA said the masks were the first “medical devices identified as being in critical shortage during the public health emergency.”

“Throughout the COVID-19 pandemic, one of the FDA’s top priorities has been to ensure frontline health care workers have access to the critical protections they need,” said Suzanne Schwartz, M.D., M.B.A., director of the FDA’s Center for Devices and Radiological Health’s Office of Strategic Partnerships and Technology Innovation., in a news release.

“We have worked very closely with our partners at NIOSH, the Occupational Safety and Health Administration and with U.S. manufacturers to stabilize, rebuild and secure health care access to high-quality, single-use respirators, including those that are American-made.

Today, our national capacity for production of these devices is stronger and our supply chain is more resilient because of these collective efforts on behalf of the dedicated people working to save lives.”

The FDA said it is required by law to maintain a device shortage list so the public can be notified and aware when supply is limited.


Where to buy N95 and KN95 face masks, available for purchase now.

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