FDA removes N95 respirators from list of medical device shortages


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The Food and Drug Administration has removed N95 respirators from the list of medical device shortages as increased manufacturing has helped build a sufficient supply of the devices.

In a statement on Friday, the agency wrote that “demand or projected demand for this type of facial protection device commonly used in healthcare settings no longer exceeds supply.”

The agency said the action was due to increased domestic manufacturing of N95 respirators, updates to the FDA’s supply chain assessment, and the approval of new disposable N95s and of reusable respirators by the National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention.

Suzanne Schwartz, director of the Office of Strategic Partnerships and Technology Innovation at the FDA’s Center for Devices and Radiological Health, said in Friday’s statement that “our national capacity to produce these devices is stronger and our supply chain supply is more resilient thanks to these collective efforts”. on behalf of the dedicated people working to save lives.

Shortages of personal protective equipment, such as N95s, have been a concern throughout the pandemic as they are key tools in stopping the spread of COVID-19.

Ventilators were among the first devices to experience a critical shortage when the public health emergency began in 2020, according to the FDA.

During the pandemic, the FDA issued emergency use authorizations for personal protective equipment to help increase supply, including for respirators, face shields and EUA coverage for some disposable surgical masks. for single use.

In July, the FDA removed surgical masks and medical gowns from its medical device shortage list.


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