On this page:

• General Questions
  • Manufacturers and Importers
  • Health Care Personnel
• Questions about Imported, Non-NIOSH Approved Respirators
  • Manufacturers and Importers
• Questions about Non-NIOSH Approved Respirators Manufactured in China
  • Manufacturers and Importers
  • Health Care Personnel

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) exist for Non-NIOSH-Approved Respirators?

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

• Imported, Non-NIOSH Approved Disposable Filtering Facepiece Respirators
  • Authorized Respirator List: Exhibit 1
• Non-NIOSH Approved Disposable Filtering Facepiece Respirators Manufactured in China
  • Authorized Respirator List: Appendix A

Questions for Manufacturers and Importers

Q: Can I import respirators to the United States if they are not authorized under the EUAs listed above?

A: Respirator manufacturers who are not included under the existing EUAs can submit a separate EUA request if they would like to import their product into the United States for use in health care settings. However, 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 the above-mentioned EUAs because the available information at this time indicates that authorizing additional respirator models of this type is neither necessary nor practicable considering decreased U.S. market demand for these respirators and the Agency's time and resource constraints.

For general background on EUAs, refer to the FDA guidance document, Emergency Use Authorization of Medical Products and Related Authorities. If you wish to submit a request for an individual EUA, the request should be submitted to CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov with the text "Individual EUA, 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: Does a non-NIOSH approved respirator manufactured outside of the United States need to be on Appendix A (if manufactured in China) or Exhibit 1 (if manufactured elsewhere) in order to import and distribute it?

A: Respirators labeled as "respirators" and 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 or Exhibit 1 of the EUAs, please see FDA's 510(k) database, or the NIOSH certified equipment list.

For more information about FDA's policies with respect to face masks and respirators, please see the FDA guidance titled 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.

Q: What options may I consider if my non-NIOSH-approved disposable filtering facepiece respirator model manufactured outside the United States 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 the above-mentioned EUAs because the available information at this time indicates that authorizing additional respirator models of this type is neither necessary nor practicable considering decreased U.S. market demand for these respirators and the Agency's time and resource constraints.

Question for Healthcare Personnel

Q: What should healthcare personnel know about the October 2020 changes to the China FFR EUA and the March 2021 changes to the Imported FFR EUA? What actions should they take as a result?

A: A healthcare facility should check Exhibit 1 or Appendix A of the two above-mentioned EUAs to determine if the non-NIOSH-approved respirators it has purchased or is considering purchasing are authorized. Healthcare facilities with non-NIOSH-approved respirators manufactured outside of the United States that are intended for a medical purpose that are not listed in Exhibit 1 or 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.

As a reminder, the authorization of a respirator under these EUAs 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 applicable EUA is revoked.

Questions about Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators

Q: Why did the FDA re-issue the EUA for imported, non-NIOSH-approved disposable filtering facepiece respirators?

A: Since initial issuance of this EUA, 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 non-NIOSH-approved respirators imported from countries other than China and NIOSH-approved N95 respirators in the United States.

Based on FDA's current review and considering previous revisions and all available information, FDA concluded that reissuance of this EUA is appropriate.

Questions for Manufacturers and Importers

Q: Will any new, Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators manufactured be added to Exhibit 1 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 March 24, 2021, 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 Exhibit 1 based on those criteria. Only those respirators listed in Exhibit 1 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 Exhibit 1 of this EUA, and have not received a decision from the FDA, what will happen to my request?

A: As a result of the March 24, 2021 reissuance, the EUA now only authorizes the respirator models that are listed in Exhibit 1 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 Exhibit 1 based on those criteria. Please see "What options may I consider if my imported, non-NIOSH-approved disposable filtering facepiece respirator model is not authorized?" above.

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: Since initial issuance of this EUA, 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 FDA's recent review and considering previous revisions and all available information, FDA concluded that reissuance of 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.

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 October 15, 2020, 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?" above.