N95 supply no longer in shortage, FDA reports

The U.S. Food and Drug Administration (FDA) officially removed N95 respirators from its list of medical device shortages, deeming the personal protective equipment (PPE) in sufficient supply now after supply chain issues that roiled much of the COVID-19 pandemic.

While the agency will continue to monitor the supply chain, at this time, it updated the supply chain assessment for industry and federal stakeholders and noted that domestic manufacturing of the N95 respirators had increased. Further, the situation has been improved by the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health’s approval of new, disposable N95 and other reusable respirators.

“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,” Dr. Suzanne Schwartz, director of the FDA’s Center for Devices and Radiological Health’s Office of Strategic Partnerships and Technology Innovation, said. “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 determines when supplies of certain devices are or are not able to meet demand/projected demand, and PPE, like N95s, is a prominent component of those checks. During the public health emergency declared for COVID-19, respirators like these were one of the first devices to suffer a critical shortage.