Can respirator standards used in other countries, such as KN95, be used in the US during the COVID-19 pandemic?
Can respirators approved under standards used in other countries, such as KN95, be used in the US during the COVID-19 pandemic?
Yes. The FDA is working diligently to mitigate any potential shortages in the supply chain and taking action to assure health care personnel on the front lines have sufficient supplies of respiratory protective devices. The FDA concluded, based on the totality of scientific evidence available, that certain imported respirators that are not NIOSH-approved are appropriate to protect the public health or safety.
On March 24, 2020, the FDA issued an Emergency Use Authorization (EUA) for importing non-NIOSH-approved N95 respirators. Under this EUA, among other criteria, the FDA accepts marketing authorization from Australia, Brazil, Europe, Japan, Korea and Mexico who have similar standards to NIOSH. The FDA did not list KN95 respirators made per China’s standards in this EUA because of concerns about fraudulent products listed as KN95s. On April 3, 2020, in response to continued respirator shortages, the FDA issued a new EUA for non-NIOSH-approved N95 respirators made in China, which makes KN95 respirators eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator is authentic.
The FDA also issued guidance to provide a policy to help expand the availability of general use face masks for the general public and respirators for health care professionals during this pandemic. The guidance applies to KN95 respirators as well. It explains that for the duration of the pandemic, when FDA-cleared or NIOSH-approved N95 respirators are not available, the FDA generally would not object to the importation and use of respirators without an EUA, including KN95 respirators, if they are on the Centers for Disease Control and Prevention (CDC) list of respirator alternatives during the COVID-19 pandemic. Although not required, if a KN95 respirator does not have an EUA, importers may want to take appropriate steps to verify authenticity of these products.
The FDA is ready and available to engage with importers to minimize disruptions during the importing process. The FDA established a special email inbox, COVID19FDAIMPORTINQUIRIES@fda.hhs.gov, for industry representatives to quickly communicate with the agency and address questions or concerns.
Read Full Article here: