We Have Come Full Circle: FDA Will No Longer Authorize Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China

On October 15, 2020, FDA reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) manufactured in China that are not approved by the CDC’s National Institute for Occupational Safety and Health (NIOSH). Effective immediately, for emergency use, FDA will authorize only those respirators currently listed in the EUA’s Appendix A (List of Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China).¹  The agency will continue to allow the emergency use of the respirator models that have already been added to Appendix A, in order to mitigate any current shortages of FFRs.²  However, the agency also stated that it would no longer “review requests nor add to the list of authorized respirators . . . .”³  FDA first issued the EUA on April 3, 2020, during the early stages of the pandemic, after initially leaving China off the list of foreign countries that were part of an umbrella EUA for imported non-NIOSH approved FFRs.⁴

According to the agency, after conducting a respirator shortage assessment to determine the current availability of both NIOSH-approved N95s and KN95⁵  respirators, it concluded that the KN95 respirator models that have already been authorized by the EUA are sufficient to help meet the demand for these respirators in the United States.  As part of the assessment,

[FDA] heard directly from health care personnel that the KN95 design has limited adoption in health care settings; from distributors that imported non NIOSH-approved product from China and the product is sitting in warehouses unused; and from manufacturers that NIOSH-approved N95 production is increasing.  Additionally, CDC/NIOSH continues to issue more N95 approvals.⁶ 

As noted above, FDA is no longer reviewing requests submitted based on the June 6, 2020 EUA criteria.⁷  The June 6, 2020 revision to the EUA significantly tightened the criteria that needed to be met by Chinese Manufacturers in order to be added to Appendix A to address “continued questions and concerns about substandard products.”⁸  It also removed decontaminated respirators from the scope of authorized products such that authorized respirators that were listed in Appendix A were no longer authorized if decontaminated.⁹  FDA initially revised the EUA on May 7, 2020, after a number of KN95 respirators “failed to demonstrate a minimum filtration efficacy of 95 percent in testing conducted at NIOSH.”¹⁰  Consequently, at that time, FDA revoked authorization to more than 60 manufacturers that failed to meet the minimum filtration requirements to be able to protect health care providers.¹¹

As a result of the latest agency action, FDA expects that it will be able to refocus the staff and resources that were tasked with reviewing these submissions to “other critical needs during the COVID-19 public health emergency, including continuing to work with CDC/NIOSH to help facilitate the availability of respiratory protection that meets the applicable standards and demand of health care personnel.”¹² 

AGG Observations

• Given FDA’s initial reluctance to authorize the importation of KN95 respirators, it is not surprising that the agency has decided to stop reviewing and authorizing FFRs under this EUA. FDA reluctantly authorized the importation of KN95s in April 2020 after facing criticism, and mounting pressure due to the shortage of personal protective equipment, for not adding China to the list of foreign countries allowed to import Non-NIOSH-approved FFRs into the United States.¹³

• According to FDA, distributors of KN95s have product sitting in warehouses while there is still a pandemic, this is an indicator of the public losing confidence in these products after the agency has released various reports outlining significant quality and performance issues.

• Manufactures that are waiting for decisions on requests to be added to Appendix A, as of October 15, 2020, should start to review other potential options for their products. FDA has made it clear that it will not review any additional requests at this point.

• While FDA is no longer authorizing FFRs from China under this EUA, there may be other options for manufacturers and distributors seeking to bring these products in from China. For example, FDA has authorized the use of face masks that meet certain criteria for use by the general public, as source control (i.e., not as personal protective equipment).  It may be that the product meets the criteria set forth in the umbrella face mask (non-surgical) EUA.¹⁴

• With Coronavirus cases on the rise across the United States, it is not inconceivable that FDA could yet again revise this EUA to allow manufacturers from China to be added to Appendix A. At this point, we will have to wait and see whether it was premature for the agency to take this action while the country is still in the middle of a pandemic.

[1] FDA News Release, titled, “FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China,” available at https://www.fda.gov/news-events/press-announcements/fda-reissues-emergency-use-authorization-certain-non-niosh-approved-filtering-face-piece-respirators.

[2] Appendix A can be found here https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#nonniosh

[3] FDA News Release, titled, “FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China,” available at https://www.fda.gov/news-events/press-announcements/fda-reissues-emergency-use-authorization-certain-non-niosh-approved-filtering-face-piece-respirators.

[4] See Forbes.com’s article, titled, “FDA Reverses Course, Approves China’s Equivalent of The N95 Mask To Protect Against Coronavirus, “ available at https://www.forbes.com/sites/rachelsandler/2020/04/03/fda-reverses-course-approves-chinas-equivalent-of-the-n95-mask-to-protect-against-coronavirus/#351c1e4816cb

[5] KN95 stands for the regulatory standard for filtering face-piece respirators that are certified in China.

[6] FDA News Release, titled, “FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China,” available at https://www.fda.gov/news-events/press-announcements/fda-reissues-emergency-use-authorization-certain-non-niosh-approved-filtering-face-piece-respirators.

[7] The June 6, 2020 letter included five main revisions to the May 7, 2020 letter:

First, FDA revised the second eligibility criterion to limit the jurisdictions to only certain CE mark    (European Economic Area certification mark) FFRs in addition to respirators that have an NMPA    certification (which was included in the May 7, 2020 revision). Second, FDA revised the third criterion such that a respirator model that is sampled by FDA and tested by NIOSH, and that has results according to NIOSH that indicates one or more of the 30 sampled respirators has a filtration efficiency of less than 95% is no longer authorized. Third, FDA revised the Scope of Authorization to remove from the authorization decontaminated respirators. Fourth, FDA added Conditions of Authorization to require samples for testing when requested by FDA and prevent distribution of shipments that fail testing. Fifth, FDA added Conditions of Authorization regarding printed materials, advertising, and promotion under section 564(e)(4) of the Act. 

See footnote 4 of EUA, available at https://www.fda.gov/media/136664/download.

[8]Id.

[9]Id.

[10] See “Certain Filtering Facepiece Respirators from China May not Provide Adequate Respiratory Protection – Letter to Health Care Providers, available at https://www.fda.gov/medical-devices/letters-health-care-providers/certain-filtering-facepiece-respirators-china-may-not-provide-adequate-respiratory-protection-letter

[11] See Respirator Models Removed from Appendix A, available at https://www.fda.gov/media/137928/download (last updated on June 12, 2020).

[12] See FDA News Release, titled, “FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China,” available at https://www.fda.gov/news-events/press-announcements/fda-reissues-emergency-use-authorization-certain-non-niosh-approved-filtering-face-piece-respirators.

[13] Available at https://www.fda.gov/media/136403/download.

[14]Available at https://www.fda.gov/media/137121/download.