The FDA said yesterday that certain imported respirators (FFRs) may be eligible for emergency use authorization (EUA) to protect public health and safety during the coronavirus outbreak.
The FDA said these these devices, imported from Australia, Brazil, Europe, Japan, Korea and Mexico, may be effective in protecting healthcare workers from airborne COVID-19 particulates, “based on the totality of scientific evidence available to FDA.” Unlike the N95 respirators that the agency approved last week for healthcare worker use, these are not certified by the National Institute for Occupational Safety and Health.
The latest EUA also includes disposable respirators that have received the European CE Mark, the Australian Register of Therapeutic Goods (ARTG) certificate of inclusion, the Health Canada Licence or approval from the Japan Pharmaceuticals and Medical Device agency.
The FDA asked that manufacturers and importers of respirators that meet the requirements outlined here contact the agency to request emergency use authorization.