The Food and Drug Administration (FDA) has removed N95 respirators from the medical device shortages list. These face protection devices had been in critical shortage and high demand since the start of the COVID-19 pandemic.

Increased domestic manufacturing, updates to the FDA’s supply chain assessment, and approval from the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health (NIOSH) of new disposable N95s and reusable respirators allowed for the removal of these respirators from the device shortage list.

“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, MD, MBA, director of the FDA’s Center for Devices and Radiological Health’s Office of Strategic Partnerships and Technology Innovation. “We have worked very closely with our partners at NIOSH, the Occupational Safety and Health Administration and with US manufacturers to stabilize, rebuild and secure health care access to high-quality, single-use respirators, including those that are American-made.”

The removal of N95 respirators from the device shortages list does not impact current policies that allow for expanded availability of face protection devices. These include the Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency guidance and the NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency EUA.

Reference

US Food and Drug Administration. FDA removes N95 Respirators from medical device shortage list, signaling sufficient supply. News release. Accessed August 29, 2022. https://www.prnewswire.com/news-releases/fda-removes-n95-respirators-from-medical-device-shortage-list-signaling-sufficient-supply-301613233.html