FAQs on Shortages of Surgical Masks and Gownsadmin
Q2. 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 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 meets certain standards.
The FDA also issued guidance outlining 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. Although not required, if a KN95 respirator does not have an EUA, the FDA encourages importers to take the appropriate steps to verify the product’s authenticity prior to importing.
The FDA has adjusted its import screening to further expedite imports of legitimate products and is continually monitoring its import systems to prevent and mitigate any potential issues. 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. The FDA is ready and available to engage with importers to minimize disruptions during the importing process.