A Medical Device Daily
The FDA has cleared for marketing the first respirators designed to help reduce the user's exposure to airborne germs during a public health medical emergency, such as an influenza pandemic.
These two filtering facepiece respirators, manufactured by 3M (St. Paul, Minnesota) and called the 3M Respirator 8612F and 8670F, will be available to the general public without a prescription.
The devices are also certified as N95 filtering facepiece respirators by the National Institute for Occupational Safety and Health (NIOSH), which certifies respirators for use in occupational settings.
An N95 filtering facepiece respirator is a type of face mask that fits tightly over the nose and mouth. It is made of fibrous material that is designed to filter out at least 95% of very small airborne particles.
"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, MD, director, 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 said it will "soon" issue guidance outlining its regulatory approach to this new type of device.
Many companies make N95 respirators for workplaces, including health care settings. However, the agency said that the 3M respirators are the first devices to receive FDA clearance for use by the public during public health medical emergencies to reduce exposure to airborne germs.
Under Occupational Safety and Health Administration (OSHA) and other occupational health regulations, respirators used in the workplace must be individually selected for each worker and tested to ensure a proper fit. This kind of fit testing is not generally employed outside the workplace now and would probably not be feasible during a public health medical emergency.
FDA is requiring those who want to market respirators for use during public health medical emergencies to assure that they are certified by OSHA to provide adequate filtration without hampering people's ability to breathe. In addition, companies must conduct fit assessment testing, conduct biocompatibility testing to reduce the chance for allergic skin reaction, and provide instructions that will enable wearers to achieve a protective fit and use the devices properly.