FDA takes N95 respirators off medical device shortage list

May 05, 2023

Respirators were one of the first medical devices identified as being in critical shortage during the COVID-19 public health emergency, the agency said.

The Food and Drug Administration has taken N95 respirators off of the medical device shortage list as increased manufacturing has helped build a sufficient supply of the devices.

In a Friday statement, the agency wrote that the "demand or projected demand for this type of face protection device commonly used in health care settings no longer exceeds the supply."

The agency said that the action was due to increased domestic manufacturing of N95 respirators, updates to the FDA's supply chain assessment, and the approval of new disposable N95s and reusable respirators by the Centers for Disease Control and Prevention's National Institute for Occupational Safety and Health.

Suzanne Schwartz, director of the FDA's Center for Devices and Radiological Health's Office of Strategic Partnerships and Technology Innovation, said in the Friday statement that "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."

Shortages of personal protective equipment, such as N95s, have been a concern throughout the pandemic as they are key tools to stop the spread of COVID-19.

Respirators were some of the first devices to be in critical shortage when the public health emergency began in 2020, according to the FDA.

Over the course of the pandemic, the FDA has issued emergency use authorizations (EUAs) of personal protective equipment to help increase the supply, including for respirators, face shields, and a blanket EUA for certain disposable, single-use surgical masks.

In July, the FDA took surgical masks and medical gowns off of its medical device shortage list.