The FDA has authorized the use of certain industrial respirator masks for healthcare workers during the coronavirus outbreak.
The N95 disposable filtering facepiece respirators have been approved by the National Institute for Occupational Safety and Health (NIOSH) as non-powered air-purifying particulate respirators. Healthcare workers will be allowed to use these, including those that have passed the manufacturers’ recommended shelf-life, to prevent exposure to the novel coronavirus, which causes COVID-19.
The FDA has allowed emergency-use non-cleared devices during previous health emergencies, including the Zika virus outbreak in 2016, the enterovirus outbreak in 2015 and the ebola virus outbreak in 2014.
Manufacturers and government-designated “strategic stockpilers” of the respirators included in this emergency authorization must notify the FDA of adverse events related to their use, according to a letter from CDC director Dr. Robert Redfield.
More information is available here.