Two N95 Respirators Certified for Public Use in Health Emergencies

Two 3M respirators received clearance for marketing and will be available to the general public without a prescription for use during public health emergencies such as a flu pandemic, FDA announced last week. The two are numbered 8612F and 8670F and are certified by NIOSH as N95 filtering facepiece respirators.

"While the exact nature and concentration of the biological agent or germ may not be known in a public health medical emergency, we believe that minimizing exposure will help reduce risk," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "These respirators are only one part of a combination of approaches that can be used to help reduce the spread of infection between individuals during such events."

FDA acknowledged fit testing would not be feasible during a general public health emergency. Companies that want to market respirators for use in such events must provide assurance their devices are NIOSH-certified, must conduct fit assessment testing and biocompatibility testing to reduce the likelihood of allergic skin reactions, and must provide instructions that will enable users to achieve a protective fit and use the respirators property, the agency said.

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    June 2019

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