May 2007 - FDA Clears First Respirators for Use in Public Health Medical Emergencies

The U.S. Food and Drug Administration (FDA) has cleared for marketing the first respirators that can help reduce the user's exposure to airborne germs during a public health medical emergency, such as an influenza pandemic.

These two respirators, manufactured by St. Paul, Minn.-based 3M Company (and called the 3M Respirator 8612F and 8670F), will be available to the general public without a prescription. These respirators are also certified as N95 filtering facepiece respirators by the National Institute for Occupational Safety and Health (NIOSH).

The 3M respirators are sized for adults and may not form a proper fit on children. Anything that comes between the respirator and the face, such as facial hair, may interfere with its fit. Persons with pre-existing heart or lung disease, or other health conditions, may have difficulty breathing through a respirator. The devices are for single use. Wearers should not wash, disinfect, reuse, or share their respirator with others. The respirators should be discarded after use.

FDA will soon issue a guidance document outlining its regulatory approach to this new type of device. Additional information on the subject may be found at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01630.html.

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