The FDA has removed respirators made by 60 companies in China from its emergency use authorization (EUA) list for COVID-19 over concerns that they may be “sub-standard.”
The list, which had totaled 74 manufacturers when issued April 24, still includes 15 models of N95 respirators made in China by 3M (NYSE:MMM), plus a number of models made by 13 Chinese companies. The FDA issued its first respirator EUA list March 24, including masks made by companies in Europe, Australia, Brazil, Japan, Korea and Mexico. At the time, the agency declined to authorize respirators made in China for use by U.S. healthcare workers over concerns about fraudulent masks.
Pressure to ease the shortage of respirators in New York and elsewhere led the agency to add Chinese-made masks to the list, even though they were not approved by the National Institute of Occupational Safety and Health (NIOSH), which is part of the Centers for Disease Control and Prevention (CDC). The FDA issued the new, longer list April 7, and said today that it had been fielding questions and complaints about some of the respirators on that new list. After the April 7 authorization, NIOSH began working with the FDA to assess the filter efficiency for respirators certified by other countries’ authorities.
NIOSH has completed more than 60 assessments of respirators from China that were on the April 3 list and has found a greater than 60% failure rate, according to an FDA spokesperson. Although more than 50 of those respirators had not been authorized by the FDA, seven were authorized under one of its criteria but failed to filter more than 95% of small particulates that might carry the COVID-19 virus.
The FDA said today it will no longer accept a manufacturer’s assurance that its respirator meets the NIOSH performance standard. It also removed all companies that it had authorized based on submission of an independent test report.
“We recognize that many of these respirators may still meet expected performance but, out of an abundance of caution, we are taking this action,” the spokesperson told MassDevice.
Companies whose authorization was pulled because they provided documentation of independent testing but have not had their products tested by NIOSH may ask to be included on the updated list after a NIOSH test and within 45 days of the updated EUA. If the respirators pass the 95% filtration test and there are no other authenticity concerns, the FDA will return them to the list, but they will be subject to random sampling once imported to the United States. Those that fail the NIOSH test may be re-labeled as face masks, which the FDA does not consider to be personal protective equipment for healthcare workers.
The agency did not have readily available data on the number of respirators affected by this decision.
“This is an unprecedented pandemic, and while the FDA continues to take action to balance the urgent need of supplies of respirators for healthcare personnel, we are also doing everything in our authority to ensure healthcare personnel receive adequate protection,” the spokesperson said. “We will continue to collaborate with the CDC to increase the availability of respirators and ensure the integrity of these products.”
Separately, 3M said today that it has won two new contracts from the U.S. Department of Defense to produce another 39 million N95 respirators per month in the U.S., while an additional unspecified investment is set to add another 22 million per month, bringing 3M’s N95 production to more than 95 million per month.
The company added that it is still working with the Trump administration to import 166.5 million respirators from 3M’s overseas manufacturing facilities in China and elsewhere over the coming months.
This article has been updated with more information from the FDA.