FDA Revokes Emergency Use Authorizations for Non-NIOSH-Approved Disposable Respirators and Decontamination Systems as Access to FDA-authorized and NIOSH-approved N95s Increases Nationwide
On June 30, 2021, the FDA announced the revocation of the following EUAs:
- Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (effective July 6, 2021)
- Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (effective July 6, 2021)
- Decontamination and Bioburden Reduction System EUAs for Personal Protective Equipment (effective June 30, 2021)
As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings. For additional information, please see Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities.
Historical information regarding these EUAs can be found on Historical Information about Device Emergency Use Authorizations.
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). Based on the FDA's increased understanding of the performance and design of these respirators, the FDA has decided that these respirators should not be decontaminated for reuse by health care personnel. As such, the FDA has revised and reissued the May 7, 2020, EUA.
On May 7, 2020, the FDA reissued the April 3, 2020 EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China to revise the third eligibility criterion – 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 but were no longer authorized based on this revision.1 The FDA took this public health action primarily because a number of these respirators failed to demonstrate a minimum particulate filtration efficiency of 95 percent in testing conducted at NIOSH.
On June 6, 2020, the FDA further revised this criterion such that respirators that are authorized under this criterion and that do not meet performance expectations are no longer authorized. Respirators that have a failing grade as indicated by NIOSH testing may be re-labeled as face masks and authorized as face masks for use as source control if certain criteria are met under the Face Mask umbrella EUA. For other information, please see the FDA's enforcement policy on face masks, as described in the Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) Guidance.
Non-NIOSH-approved disposable filtering facepiece 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 of the EUA 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 disposable filtering facepiece respirators manufactured in China have been tested and to review the testing results.
- A complete list of Respirator Models No Longer Authorized is available on our website.
- 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 if they do not have exhalation valves, 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 NIOSH 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.
- At this time and based on the available information, the FDA believes that any respirators listed 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 based on the May 7, 2020, update to the third criterion 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:
- 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" are subject to different requirements from products labeled as "respirators." "Face masks" do not need to be on Appendix A to the reissued EUA, or on Exhibit 1 to the June 6, 2020, EUA for imported respirators, to be imported and distributed in the United States. But face masks are not considered PPE. For more information, please see the Face Mask umbrella EUA which authorizes face masks that meet certain criteria, as well as the Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised).
- Consistent with CDC's recommendations, HCP should use an FDA-cleared or NIOSH-approved respirator before another authorized, imported respirator, when available. 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 available to FDA, it is reasonable to believe these 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 June 6, 2020, Imported, Non-NIOSH Approved Disposable Filtering Facepiece Respirators Emergency Use Authorization for respirators manufactured in other countries, or Appendix A of the Emergency Use Authorization for Non-NIOSH Approved Disposable Filtering Facepiece Respirators manufactured in China. The lists in Appendix A and in Exhibit 1 are updated on a rolling basis as new information becomes available for FDA to review.
- Consider asking questions of the seller and 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 "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 pose difficulty achieving a proper fit. Follow your health care facility's guidelines for conducting fit testing.
- If a used respirator that is FDA-cleared or NIOSH-approved is available and a new respirator covered under one of the FDA Emergency Use Authorizations for respirators is not available, you may consider decontaminating and reusing the used respirator with a decontamination system that has an FDA Emergency Use Authorization, if the used respirator is compatible with the decontamination system.
- If your facility is using respirators that have been removed from Appendix A, these respirators are no longer authorized by FDA for single use or for reuse by an FDA authorized decontamination system.
- Additionally, as of June 6, 2020, any KN95 respirator, or any respirators with exhalation valves, should not be decontaminated and are no longer authorized to be decontaminated by any authorized decontamination systems.
- 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.
See Frequently Asked Questions (FAQs) about Non-NIOSH-Approved Filtering Facepiece Respirators for more information.
The FDA continues to actively monitor and take action to 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.
Additionally, on June 6, 2020, the FDA reissued the Emergency Use Authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China by revising the Scope of Authorization to revise that authorized respirators listed in Appendix A will no longer be authorized if decontaminated. The FDA also reauthorized the EUAs for multiple decontamination systems so that these decontamination systems are no longer authorized to decontaminate respirators manufactured in China nor are they authorized to decontaminate respirators with exhalation valves, where applicable. For more information on the FDA's revised EUAs on respirators and decontamination systems, please see the FDA's press release.
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 Respirator Models No Longer Authorized-COVID19 document.
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?"
- NIOSH's Healthcare Respiratory Protection Resources Fit Testing
- The Occupational Safety and Health Administration's (OSHA) video about Respiratory Protection Fit Testing
- The CDC's Counterfeit Respirators/Misrepresentation of NIOSH-Approval and Factors to Consider When Planning to Purchase Respirators from Another Country provides information about recognizing counterfeit respirators, recommended best practices for proper respirator use, and to assist buyers in making procurement decisions.
1 However, respirators previously authorized by meeting the original third eligibility criterion (i.e., review of independent test lab reports) for which manufacturers have requested FDA sample collection and NIOSH testing and have 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, within 45 days of EUA reissuance on May 7, 2020, are eligible for authorization under the revised third criterion and are listed on Appendix A.