In a joint effort, FDA and the Centers for Disease Control and Prevention (CDC) took action to make more respirators, including certain N95s, available to healthcare personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. The agencies’ action allows certain National Institute for Occupational Safety and Health (NIOSH)-approved respirators not currently regulated by FDA to be used in a healthcare setting by healthcare personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the US healthcare system.
“President Trump has made it clear that protecting the American people is his top priority, and that includes taking every necessary step to ensure America’s healthcare providers have the tools they need,” says HHS Secretary Alex Azar. “FDA and CDC’s action to allow a wider range of respirators to be used in healthcare settings will help those on the front lines of this outbreak and their patients, which will keep all Americans safe. We will continue pursuing every possible avenue to secure the protective gear needed for responding to the COVID-19 outbreak.”
Respiratory protective devices are designed to achieve a very close facial fit and very efficient filtration of airborne particles. When properly fitted, respirators such as N95s can filter more airborne particles than face masks, which is important during an outbreak of a respiratory disease like COVID-19. FDA regulates respirators intended for use in a healthcare setting, however, most respirators are used in construction and other industrial jobs only and are therefore not required to meet the FDA requirements for testing.
FDA granted CDC’s request for an emergency use authorization (EUA) to allow healthcare personnel to use certain industrial respirators during the COVID-19 outbreak in healthcare settings. FDA concluded that respirators approved by NIOSH, but not currently meeting FDA requirements, may be effective in preventing healthcare personnel from airborne exposure, including COVID-19, which can cause serious or life-threatening disease, including severe respiratory illness. Given the increased demand and supply challenges on the availability of respirators, today’s EUA helps to provide alternatives that can enable more healthcare personnel to have access to this potentially lifesaving personal protective equipment. This action is the result of the close collaboration between FDA and CDC to prioritize access to needed medical products during this outbreak to support healthcare personnel.
For further information, visit FDA.