The U.S. FDA announced the removal of N95 respirators from its medical device shortage list, signaling that demand—or projected demand—for this type of face protection device commonly used in healthcare settings no longer exceeds the supply.
This action is the result of increased domestic manufacturing of N95 respirators, as well as updates to the FDA’s supply chain assessment based on engagement with 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.
“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,” says 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 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.”
Since the start of the pandemic, the FDA has been closely monitoring the respirator supply chain and working with federal partners and industry to address critical shortages of personal protective equipment (PPE), including respirators, which were one of the first medical devices identified as being in critical shortage during the public health emergency.
The FDA has taken many actions to provide flexible policies and help ensure that patients and health care providers have timely and continued access to high-quality medical devices. These actions included issuing Emergency Use Authorizations (EUAs) and guidance documents to provide recommendations and help expand the availability and capability for various protective medical devices in high demand during the COVID-19 public health emergency.
The FDA is required by law to maintain a device shortage list to provide transparency to the American public, particularly those who use or purchase medical devices. The FDA determines it is appropriate to remove a product code from the device shortage list when the agency finds the demand or projected demand for the device no longer exceeds the supply for a period of time.
The FDA continues to take a phased approach to ensuring the availability of PPE and supply chain impacts. The removal of respirators from the device 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. These policies remain in effect. The FDA will continue to monitor the supply chain and update the device shortage list and device discontinuance list as the COVID-19 public health emergency evolves.