The Food and Drug Administration today issued a final order exempting manufacturers from FDA premarket notification requirements for certain N95 respirators, disposable devices used to protect patients and health care providers from infection. Under a new memorandum of understanding between the FDA and National Institute for Occupational Safety and Health, organizations seeking to market N95 respirators that do not exceed certain criteria need only NIOSH certification. The final order and MOU, effective tomorrow, are intended to streamline regulatory requirements to help ensure adequate supply of the devices during public health emergencies.

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