On April 3, 2020, FDA eased restrictions on mask requirements to allow certain N95s to be exported from China into the United States. However, FDA is concerned that certain filtering facepiece respirators (respirators) from China may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19 based on additional filtration performance testing. FDA has therefore revised and reissued the April 3, 2020 Emergency Use Authorization. FDA will now only allow imports from manufacturers who were already certified in the US or regions outside of China, including those in the EU. The revised list includes only 14 manufacturers, down from about 80 (https://www.fda.gov/media/136664/download). Any respirators that were previously on the list but no longer on the list are no longer eligible or authorized to be marketed or distributed in the US as respirators.
However, these respirators may be relabeled as face masks and authorized if certain criteria are met under the face mask EUA. This means that the product must now be identified as a face mask (not a respirator) and the labeling must include explicit recommendations against use in a clinical setting where the infection risk level through inhalation exposure is high. There are additional labeling and marketing restrictions, as well as specific disclaimers that must be stated about the product. Manufacturers must institute certain regulatory processes as well. We are already advising clients on how to market their products in this way and we can help with the language and requirements.
The U.S. Food and Drug Administration (FDA) is concerned that certain filtering facepiece respirators (respirators) from China may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19 based on additional filtration performance testing.