N95 Respirators Removed From FDA’s Medical Device Shortage List

The U.S. Food and Drug Administration has removed N95 respirators from its medical device shortage list, indicating its sufficient supply mainly with increased domestic manufacturing.

An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles.

Surgical N95 Respirators, commonly used in healthcare settings, are a subset of N95 Filtering Facepiece Respirators or FFRs, often referred to as N95s.

According to the agency, the demand or projected demand for this type of face protection device generally used in health care settings no longer exceeds the supply. The FDA said it continues to monitor supply chain to help ensure continued access.

The growth in supply mainly reflects increased domestic manufacturing of N95 respirators, along with updates to the FDA’s supply chain assessment based on engagement with industry and federal stakeholders. In addition, the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Healths or NIOSH has approved new disposable N95s and reusable respirators.

Since the start of the pandemic, the FDA has been monitoring to address critical shortages of personal protective equipment or PPE, including respirators.

For timely and continued access to high-quality medical devices, the agency has taken various actions such as Emergency Use Authorizations or EUAs and guidance documents to provide recommendations and help expand the availability and capability for various protective medical devices.

Suzanne Schwartz, director of the FDA’s Center for Devices and Radiological Health’s Office of Strategic Partnerships and Technology Innovation, said, “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. 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.”

The FDA’s device shortage list is maintained to provide transparency to the American public, particularly those who use or purchase medical devices.

The product code is removed from the list when the agency finds the demand or projected demand for the device no longer exceeds the supply for a period of time.

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