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  7. FAQs on the EUAs for Non-NIOSH Approved Respirators During the COVID-19 Pandemic
  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

FAQs on the EUAs for Non-NIOSH Approved Respirators During the COVID-19 Pandemic

On October 15, 2020, the FDA reissued the Emergency Use Authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China to revise the scope of authorization to authorize for emergency use only those respirators listed in the EUA’s Appendix A as of the date of this reissuance. Effective immediately, this EUA no longer includes the three eligibility criteria that were included in the previous June 6, 2020 authorization letter, meaning FDA will no longer be reviewing requests and adding new respirator models to Appendix A based on those criteria. For more information, please see the FDA’s October press release.

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General Questions

Q: Do filtering face-piece respirators (FFRs) not approved by the National Institute for Occupational Safety and Health (NIOSH) provide similar protection as NIOSH-approved respirators?

A: As mentioned in CDC's strategies for optimizing respirator supply, certain other countries approve respirators according to country-specific standards. Non-NIOSH-approved FFRs that are authorized for emergency use by FDA are evaluated using methods similar to those used by NIOSH and are expected to provide similar protection for healthcare personnel when used in healthcare settings. Under these circumstances, the FDA believes these devices may serve as suitable alternatives for personal respiratory protection during this period of shortage caused by the COVID-19 pandemic. In addition, the CDC’s National Personal Protective Technology Laboratory (NPPTL) has posted on its website Respirator Assessments to Support the COVID-19 Response.

Q: What Emergency Use Authorizations (EUAs) are available for Non-NIOSH Approved Respirators?

A: There are two EUAs available for Non-NIOSH-approved respirators:

Q: Why has the FDA provided additional specificity regarding the jurisdictions eligible for review under the Non-NIOSH Approved Respirator Imports EUA?

A: Since the Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) EUA was issued for respirators manufactured in countries other than China, the FDA has received submissions requesting addition to Exhibit 1 under the jurisdictional authorization criterion. However, the FDA has come to learn that some of the previously included regulatory jurisdictions do not review the device’s performance data as part of the certification process. As a result, the FDA has revised the Scope of Authorization such that only respirators that have a CE mark are authorized under the jurisdiction criteria.

If you are planning to request addition to Exhibit 1 based on this CE mark eligibility criterion (criterion 2), please keep in mind that you will be asked to provide the following from a competent notified body for PPE:

  • EU type examination certificate and evidence of production monitoring and/or control or of quality assurance of the production system, or
  • European Commission (EC) type examination certificate and evidence of production monitoring and/or control or of quality assurance of the production system

Please note that ICR Polska and Ente Certificazione Macchine (ECM) are not notified bodies for PPE.

Q: Can I import respirators to the United States if the standards or approval mechanism from my country is not listed as criteria for eligibility under the EUAs listed above?

A: Respirator manufacturers whose countries' standards or approval mechanism are not included under the existing EUAs should submit a separate EUA request if they would like to import their product into the United States for use in health care settings. For general background on EUAs, refer to the FDA guidance document, Emergency Use Authorization of Medical Products and Related Authorities. Requests for this particular EUA should be made to CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov with the text "Non-NIOSH-Approved Respirator" in the subject line and include:

  • General information such as your contact information, name and place of business, email address, and contact information for a U.S. agent (if any) in addition to general information about the device such as the proprietary or brand name, model number, and marketing authorization in your country (or region).
  • A copy of the product labeling.
  • Whether the device currently has marketing authorization in another regulatory jurisdiction (including certification number, if available).
  • Whether the device is manufactured in compliance with 21 CFR Part 820 or ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes or an equivalent quality system and the manufacturer or importer has documentation of such. 
  • Description of testing conducted on the device, including any standards met, such as liquid barrier protection, flammability, biocompatibility, and filtration performance, as appropriate

Q: If my respirators are authorized for use under an EUA, what do I need to do to import them? Who do I contact if my authorized respirator has import issues?

A: Import information can be found on the Information for Filing Personal Protective Equipment and Medical Devices During COVID-19 page. Please contact COVID19FDAIMPORTINQUIRIES@fda.hhs.gov or 301-796-0356 to resolve entry issues for shipments.

 


Questions about Non-NIOSH Approved Disposable Filtering Facepiece Respirators Manufactured in China

Q: Why did the FDA re-issue the EUA for non-NIOSH-approved disposable filtering facepiece respirators manufactured in China?

A: On April 3, 2020, in response to the evolving public health emergency and continued concerns about filtering facepiece respirator (FFR or respirator) availability, FDA issued an Emergency Use Authorization (EUA) in accordance with section 564 of the Federal Food, Drug, and Cosmetic Act (Act) for certain product classifications for disposable FFRs that are manufactured in China and not NIOSH-approved and for which data or other information existed to support the respirators’ authenticity. These respirators are commonly referred to as KN95s.

On May 7, 2020, in response to questions and concerns that were received by FDA after issuance of the April 3, 2020 letter, FDA reissued the letter to revise the Scope of Authorization to address concerns about sub-standard products to protect the public health or safety under section 564 of the Act.

On June 6, 2020, the FDA again reissued the EUA by revising the Scope of Authorization such that authorized respirators listed in Appendix A are no longer authorized to be decontaminated, and to further address continued questions and concerns about sub-standard products.

Since June 6, 2020, the FDA has continued to periodically review the circumstances and the appropriateness of this EUA. This review included engagement with various stakeholders to further understand the availability and use practices for KN95s and NIOSH-approved N95 respirators in the U.S.

Based on this review and considering previous revisions and all available information, FDA concluded that reissuing this EUA is appropriate.

Q: In procuring respirators manufactured in China, I believe I have identified potential fraudulent/counterfeit product. Who should I report this to?

A: 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 and its labeling.

NIOSH also maintains the Counterfeit Respirators/Misrepresentation of NIOSH-Approval page that can be used as a reference.

Q: Are authorized respirators manufactured in China intended for general public use?

A: No, respirators authorized under this EUA are personal protective equipment that are intended for use by health care personnel in health care settings according to CDC's recommendations. FDA has authorized certain face masks, such as cloth facial coverings, which are not considered personal protective equipment (PPE), for use by the general public and health care personnel as source control only to help slow the spread of COVID-19 consistent with the Face Mask (Non-Surgical) EUA.

Questions for Manufacturers and Importers

Q: Will any new, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators manufactured in China be added to Appendix A based on the June 6, 2020 EUA’s criteria?

A. No, under the June 6, 2020, authorization, a respirator was authorized if it met any of three specified eligibility criteria. Effective immediately, this EUA no longer includes the three eligibility criteria that were included in the previous June 6, 2020 authorization letter, meaning FDA will no longer be reviewing requests and adding new respirator models to Appendix A based on those criteria. Only those respirators listed in Appendix A as of the date of this reissuance are authorized by this EUA.

Q: If I submitted information requesting that my respirator(s) be added to Appendix A of this EUA, and have not received a decision from the FDA, what will happen to my request?

A: As a result of the October 15, 2020 reissuance, the EUA now only authorizes the respirator models that are listed in Appendix A as of the reissuance date, and the eligibility criteria from the previous June 6, 2020 EUA have been removed. Therefore, no additional respirator models will be added to Appendix A based on those criteria. Please see “What options may I consider if my non-NIOSH-approved disposable filtering facepiece respirator model manufactured in China is not authorized?” below.

Q: What options may I consider if my non-NIOSH-approved disposable filtering facepiece respirator model manufactured in China is not authorized?

A. You may want to consider the following:

  • For the duration of the COVID-19 pandemic, FDA has announced a policy that applies to face masks that are intended for a medical purpose that are not intended to provide liquid barrier protection (see the Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)).  FDA has also authorized the use of face masks that meet certain criteria for use by the general public, including healthcare personnel in healthcare settings, as source control (i.e., not as personal protective equipment (PPE)) as explained in the face mask (non-surgical) EUA. 
  • As explained in the enforcement policy above, FDA device marketing authorization (e.g., authorization or clearance) is not required for products that do not meet the definition of a device (e.g., the product is labeled and marketed to the general public for general, non-medical purposes, such as use in construction).
  • If you are considering submitting an individual EUA request for your respirator, please note that we do not encourage such submissions, given that FDA removed the eligibility criteria from this EUA because the available information at this time indicates that authorizing additional respirator models of this type is neither necessary nor practicable given the Agency’s time and resource constraints, and considering decreased U.S. market demand for these respirators.

Q: Does a respirator manufactured in China need to be on Appendix A in order to import and distribute it?

A: Respirators accurately and appropriately labeled as "respirators" intended for a medical purpose must be cleared or authorized by the FDA in order to be imported and distributed. In addition to Appendix A, please see FDA’s 510(k) database, or the NIOSH certified equipment list. For information about face masks, including the FDA's enforcement policy with respect to face masks and respirators, please see the Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised). Import information can be found on the Information for Filing Personal Protective Equipment and Medical Devices During COVID-19 page. If you need to resolve entry issues for shipments, please contact 301-796-0356 or COVID19FDAIMPORTINQUIRIES@fda.hhs.gov.

Question for Health Care Personnel

Q: What should health care personnel know about changes to the EUA and what actions should they take as a result?

A: Under the prior June 6, 2020, authorization, a respirator was authorized if it met any of three specified eligibility criteria. Effective immediately, this EUA no longer includes the three eligibility criteria that were included in the previous June 6, 2020 authorization letter, meaning FDA will no longer be reviewing requests and adding new respirator models to Appendix A based on those criteria. The EUA reissued on [insert date] only authorizes the respirator models that are listed in Appendix A as of the reissuance date.

A health care facility should check Appendix A to determine if the non-NIOSH-approved respirators manufactured in China it has purchased or is considering purchasing are authorized. Health care facilities with non-NIOSH-approved respirators manufactured in China that are intended for a medical purpose that are not listed in Appendix A, may wish to consider several factors in deciding whether to use these respirators, including current need, inventory, facility practices, and acceptable alternate uses, such as face masks. Health care facilities should be aware that face masks, including respirators that are relabeled as face masks for source control, are not considered personal protective equipment (PPE).

As a reminder, the authorization of a respirator under the EUA does not denote a permanent regulatory status. The emergency use of the respirator is only authorized during the period of the COVID-19 public health emergency or until the EUA is revoked.

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