The U.S. Food and Drug Administration today announced the removal of N95 respirators from the agency's medical device shortage list, signaling that demand or projected demand for this type of face protection device commonly used in health care settings no longer exceeds the supply.
The move 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.
Since the start of the pandemic, the FDA has closely monitored the respirator supply chain and worked 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 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.
