- Letter to Health Care Providers
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 conducted by the National Institute for Occupational Safety and Health (NIOSH) – National Personal Protective Technology Laboratory (NPPTL) of the Centers for Disease Control and Prevention (CDC) (referred to below as the NIOSH testing). As such, FDA has revised and reissued the April 3, 2020 EUA as explained below.
On May 7, 2020, the FDA reissued the Emergency Use Authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China to revise one of the eligibility criteria – the criterion for authorization of respirators based on review of test reports from recognized independent test laboratories submitted to the FDA by the manufacturer or importer – and accordingly removed from Appendix A the respirators that had been authorized under that criterion, regardless of whether they passed or failed the NIOSH testing.1
The FDA is taking this public health action because a number of these respirators failed to demonstrate a minimum particulate filtration efficiency of 95 percent in testing conducted at NIOSH.
Respirators that were removed from Appendix A of the EUA and that did not meet their labeled performance standard (listed below) are no longer eligible and are no longer authorized to be marketed or distributed in the United States as respirators. They may be re-labeled as face masks and authorized if certain criteria are met under the Face Mask umbrella EUA . For other information, please see FDA’s enforcement policy on face masks, as described in the April 2020 Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)” Guidance.
Non-NIOSH-approved respirators that meet the other eligibility criteria in the reissued Emergency Use Authorization remain authorized by the FDA for use during the COVID-19 pandemic and continue to be listed in Appendix A.
Health care facilities with these respirators in inventory should review the considerations listed below. The information is specific to respirators that are designed to achieve a very close facial fit and to filter airborne particles. These considerations are not applicable to surgical masks or face masks that are loose-fitting and create a physical barrier between the health care personnel’s mouth and nose and potential contaminants in the immediate environment.
Respirators that no longer appear in Appendix A may not reliably provide a minimum percent particulate filtration efficiency of 95 percent. Refer to the NIOSH assessment webpage to determine whether non-NIOSH-approved respirators manufactured in China have been tested and to review the testing results. Among products removed from Appendix A to date, the following failed to demonstrate a minimum percent particulate filtration efficiency of 95 percent in testing conducted by NIOSH: CTT Co. Ltd Daddybaby Co. Ltd Dongguan Xianda Medical Equipment Co., Ltd. Guangdong Fei Fan Mstar Technology LTD Guangdong Nuokang Medical Technology Co., Ltd. Huizhou Huinuo Technology Co., Ltd. Lanshan Shendun Technology Co NIOSH regularly updates its list of testing results. Respirators that have been tested by NIOSH and failed to demonstrate a Minimum Particulate Filtration Efficiency of 95 percent may be considered for use as face masks for source control, to help slow the spread of infection when a person speaks, coughs, or sneezes. Health care facilities should be aware that this use of face masks is different from personal protective equipment for health care personnel. Health care facilities with these respirators that failed the NOISH testing may wish to consider a number of factors in deciding to use these products as face masks, including current need, inventory, facility practices, and acceptable uses. The FDA believes respirators that no longer appear in Appendix A may not be reliably decontaminated in any decontamination system authorized for use during the COVID-19 pandemic. If you have respirators that were removed from Appendix A and you want NIOSH to test their filtration efficiency, you can request NIOSH testing by submitting the International Respirator Assessment Request.
Health care facilities may find the following information useful when considering the purchase or use of respirators such as N95s and KN95s:
Products labeled as “respirators” must meet the applicable FDA requirements or receive an Emergency Use Authorization to be imported and distributed in the United States. However, products labeled as “face masks” and not as “respirators” are subject to different requirements. They do not need to be on Appendix A to the reissued EUA, or on Exhibit 1 to the March 28, 2020, EUA for imported respirators, to be imported and distributed in the United States.
For more information, please see the Face Mask umbrella EUA which authorizes face masks that meet certain criteria, as well as the April 2020 Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised).
Use an FDA-cleared or NIOSH-approved respirator. The FDA authorized the emergency use of all NIOSH-approved air purifying respirators for use in healthcare settings during the COVID-19 public health emergency. The CDC provides a list of NIOSH-Approved Particulate Filtering Facepiece Respirators and powered air purifying respirators. If FDA-cleared or NIOSH-approved respirators are not available, consider using respirators covered under one of the other FDA Emergency Use Authorizations for respirators. Based on the totality of scientific evidence and other information from the FDA, it is reasonable to believe the authorized respirators may be effective at preventing exposure to certain particulates to prevent the spread of COVID-19.
These respirators are listed in Exhibit 1 of the March, 28, 2020, Imported, Non-NIOSH Approved Disposable Respirators Emergency Use Authorization for respirators manufactured in other countries, or Appendix A of the Emergency Use Authorization for Non-NIOSH Approved Disposable Respirators manufactured in China. The list in Appendix A is updated by the FDA regularly.
Follow due diligence practices, such as asking questions of the seller, conducting a physical assessment of the product and fit testing, to make the most informed benefit-risk decision about respirator use. Continue to ensure that careful testing or “fit testing” of respirators is conducted with health care personnel so that a very close facial fit is achieved. Many respirators manufactured in China have an ear loop design. According to the CDC, limited assessment of ear loop designs indicate there may be difficulty achieving a proper fit. Follow your health care facility’s guidelines for conducting fit testing. If a previously used FDA-cleared or NIOSH-approved respirator is available and a new respirator covered under one of the FDA Emergency Use Authorizations for respirators is not available, you may consider using an FDA Emergency Use Authorization decontamination device for reuse of a compatible contaminated respirator.
Please also note that if your facility is using respirators that have been subsequently removed from Appendix A, these respirators are no longer authorized by FDA for single use or reuse by an FDA authorized decontamination system.
If you have concerns about respirators or questions about the packaging, labeling, or quality of the respirators, consider replacing, discarding, or returning the respirators to the distributor, if appropriate.
See Frequently Asked Questions (FAQs) about Non-NIOSH-Approved Filtering Facepiece Respirators for more information.
The FDA continues to actively monitor and mitigate any potential shortages in the supply chain, including the medical device supply chain. This includes taking action to help assure health care personnel on the front lines have the necessary supplies of personal protective equipment to meet the demand.
The FDA continues to collaborate with the CDC to increase the availability and ensure the integrity of respirators during the COVID-19 public health emergency.
The FDA will continue to keep health care providers and the public informed if new or additional information becomes available.
If additional information becomes available that indicates respirators are not eligible to be authorized, they will be removed from Appendix A and this removal will be publicly communicated on the FDA’s Emergency Use Authorization page.
Reporting Problems to the FDA
The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with respirators.
Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations. Health care providers employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Fraudulent COVID-19 products pose a serious risk to public health. We encourage any concerns about potential counterfeit or fraudulent product be sent to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov. If possible, please include a description of the product along with a picture of the product’s labeling.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).
Personal Protective Equipment Emergency Use Authorizations The FDA’s Video "What is an Emergency Use Authorization?"External Link Disclaimer NIOSH’s Healthcare Respiratory Protection Resources Fit Testing The Occupational Safety and Health Administration’s video about Respiratory Protection Fit Testing The CDC’s Counterfeit Respirators/Misrepresentation of NIOSH-Approval provides information about recognizing counterfeit respirators and recommended best practices for proper respirator use.
1 However, if a respirator has passed testing by NIOSH (i.e., it demonstrated greater than or equal to 95 percent filtration efficiency per a modified version of NIOSH Standard Test Procedure (STP) TEB-APR-STP-0059), https://www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0059-508.pdf, and was previously listed in Appendix A based on meeting the original third criterion, that respirator remains authorized and listed in Appendix A under the revised third criterion.
U.S. Food and Drug Administration