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FDA Reverses Decision to Authorize Use of Chinese KN95 Respirators

Citing poor quality, the U.S. Food and Drug Administration (FDA) has barred the importation of certain KN95 filtering facepiece respirators manufactured in China. On May 7, 2020, FDA revised and reissued the Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China Emergency Use Authorization (EUA) that provided eligibility criteria authorizing the importation of respirators from China that are not approved by the National Institute for Occupational Safety and Health (NIOSH) (i.e., not certified as meeting the N95 standard). In our prior blog posts, we detailed the temporary enforcement policy regarding the manufacture and distribution of face masks and respirators during the COVID-19 public health emergency to address shortages of personal protective equipment, including FDA’s previous position that KN95 respirators could be imported without verified test reports or separate authentication. However, in a Letter to Health Care Providers, the FDA is now expressing concerns over some of the respirators from certain Chinese manufacturers, citing filtration performance testing conducted by NIOSH as evidence that such respirators do not provide adequate respiratory protection from COVID-19.

In its May 7, 2020, revisions to the EUA, FDA removed the eligibility criterion allowing importation of Chinese non-NIOSH-approved respirators based on a test report from an independent laboratory demonstrating that the respirators met an applicable filtration standard accepted by the Centers for Disease Control and Prevention. American regulators were not required to test the imported KN95 masks under the original EUA. The results from NIOSH’s recent testing of these imported respirators demonstrated that a number of them failed to establish a minimum particulate filtration efficiency of 95%, meaning the respirators did not work properly. Additionally, Chinese respirators authorized under the test report eligibility criterion, regardless of whether such respirators passed or failed the NIOSH testing, have been removed from Appendix A of the revised EUA. However, FDA added a new eligibility criterion permitting any respirator that was previously authorized under the test report criterion to be reauthorized if it demonstrates at least 95% filtration efficiency in NIOSH testing.

The FDA revisions do not affect the non-NIOSH-approved respirators meeting the other eligibility criteria in the original and reissued EUA, which remain authorized for use by FDA during the COVID-19 public health emergency.

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About this Author

Benjamin Zegarelli Health Care Attorney Mintz Levin

Benjamin provides counsel on compliance and regulatory issues to clients in the pharmaceutical, medical device, and biotech industries. With a clear focus on FDA regulatory counseling, Benjamin advises a breadth of health care industry clients on the federal and state laws surrounding manufacturer product development and marketing. His practice also includes advising clients on research approval, sales, and negotiating contractual relationships.

Benjamin has experience representing medical device companies in responding to significant unfavorable inspection observations, sometimes...

Elizabeth K. Conti Associate Mintz DC FDA Regulatory Health Care Enforcement & Investigations Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Consumer Product Safety

Elizabeth focuses her practice on regulatory compliance and enforcement defense matters for companies in the pharmaceuticals, medical device, dietary supplement, cosmetics, and food industries as well as pharmacies and distributors.

She advises clients on FDA regulations related to labeling, advertising, importing and exporting, and manufacturing practices. Her practice also encompasses administrative matters and civil litigation related to DEA requirements. On the enforcement defense side of her practice, Elizabeth counsels clients on fraud and abuse compliance and litigation involving the False Claims Act, the Stark law, and the federal anti-kickback statute.

Prior to joining Mintz, Elizabeth was a health law associate in the Washington office of a Wisconsin-based national law firm, where she assisted clients with a wide range of FDA, DEA, and health care fraud and abuse enforcement matters. Earlier, she was a winter associate at that firm.

While earning her law degree, Elizabeth also completed a clerkship at the White House Council on Environmental Quality and internships with the Environmental Protection Agency’s Office of the General Counsel and Office of Enforcement and Compliance Assurance. At law school, she served as a note & comment editor of the Catholic University Law Review.