N95 Respirators Taken off Medical Device Shortage List

The U.S. Food and Drug Administration (FDA) announced that it removed N95 respirators from the agency’s medical device shortage list.
 
This signals that demand or projected demand for this face protection no longer exceeds supply, due to increased domestic N95 manufacturing and updates of the FDA’s supply chain assessment based on engagement with industry and federal stakeholders.
 
The Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health (NIOSH) also approved new disposable N95s and reusable respirators to aid the shortage.
 
“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,” 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, told the press. “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.”
 
FDA continues to take a phased approach to ensuring availability of PPE and supply chain impacts. Removal of respirators from the shortages list does not impact the existing Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency  guidance or the NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency EUA at this time.