The FDA Reverses Course and Authorizes the Importation of Non-NIOSH Approved Respirators Manufactured in China

In response to the current public health crisis causing medical equipment shortages, on April 3, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) permitting the importation of non-NIOSH approved filtering face-piece respirators (FFRs) manufactured in China, including KN95 masks. In its original EUA from March 28, FDA had authorized importation of similar respirators from six other countries, but China was excluded, despite the Centers for Disease Control and Prevention’s (CDC’s) statement that KN95 masks are “expected to be suitable alternatives to provide protection during the COVID-19 response while supplies are short.” FDA’s new EUA aligns with the CDC’s recommendation. 

To qualify for the EUA and be eligible for importation, manufacturers of disposable non-NIOSH-approved FFRs manufactured in China must show that offered masks are authentic. Evidence of authenticity may include additional validation and review by FDA. Further, they must show that the offered masks:

1. Are manufactured by an entity that holds one or more NIOSH approvals for other models of FFRs produced in accordance with the applicable standards of authorization in other countries that can be verified by FDA;
2. Have regulatory authorization from a jurisdiction other than China that can be authenticated and verified by FDA; or
3. Demonstrate acceptable performance to applicable testing standards as documented by test reports from a recognized independent test laboratory that can be verified by FDA.

FDA may ask a manufacturer requesting authorization for additional information if the agency needs to confirm eligibility based on the criteria listed above.

This new authorization is particularly significant as products which meet the criteria listed under EUAs are eligible for protections under the Public Readiness and Emergency Preparedness Act (PREP Act). The PREP Act grants immunity from liability against claims of loss which are caused by, arise out of, relate to, or result from the manufacture, distribution, administration, or use of designated “Covered Countermeasures.” Non-NIOSH approved FFRs which fully adhere to requirements under the applicable EUA would fall under the category of “drugs, devices, or biological products authorized for emergency use,” and would therefore be considered Covered Countermeasures for the purposes of the PREP Act. Certain limitations apply to PREP Act immunity, however, as is discussed more fully in our prior client alert.