On this page:
- General Information
- Questions about Non-NIOSH Approved Respirators Manufactured in China
Q: Do filtering face-piece respirators (FFRs) not approved by the National Institutes of Occupational Safety and Health (NIOSH), provide the same protection as NIOSH-approved respirators?
A: As mentioned in CDC's strategies for optimizing respirator supply, certain other countries approve respirators according to these standards. These devices are evaluated using methods similar to those used by NIOSH and are still expected to provide adequate protection for healthcare personnel, given shortages of FFRs resulting from the COVID-19 pandemic. 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: Why has the FDA provided additional specificity regarding the jurisdictions eligible for review under the Non-NIOSH Approved Respirator Imports EUA and the Non-NIOSH Approved Respirators Manufactured in China EUA?
A: Since release of these EUAs, the FDA has received submissions seeking addition to either Exhibit 1 or Appendix A under the jurisdictional authorization criterion. However, the FDA has come to learn that 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 is revising the Scope of Authorization such that:
- For respirators under the imported, non-NIOSH-approved EUA: Only respirators that have a CE mark are authorized under the jurisdiction criteria.
- For respirators manufactured in China: Only respirators that have marketing authorization under the NMPA registration certification or CE mark are authorized under the jurisdiction criterion.
If you are planning to request addition to either Exhibit 1 or Appendix A based on this CE mark eligibility criterion, please keep in mind that one item you will be asked to provide is a type examination certificate from a competent notified body for PPE. Though we have received certificates for ICR Polska and Ente Certificazione Macchine (ECM), these are not notified bodies for PPE, and therefore certificates from these organizations are not adequate documentation for meeting this eligibility criterion.
Q: What Emergency Use Authorizations (EUAs) are available for Non-NIOSH Approved Respirators?
A: There are two EUAs available for Non-NIOSH respirators:
- Imported, Non-NIOSH Approved Disposable Filtering Facepiece Respirators
- Non-NIOSH Approved Disposable Filtering Facepiece Respirators Manufactured in China
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.
Q: Why did the FDA re-issue the EUA for non-NIOSH approved disposable filtering facepiece respirators manufactured in China?
A: Since FDA issued the April 3, 2020 EUA, new information has become available that questions the performance of some of the respirators authorized under the original April 3, 2020 EUA and included in Appendix A. For instance, FDA has received testing data from the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH), which found that some of the respirators manufactured in China and listed in Appendix A did not meet the expected performance criteria of greater than or equal to 95 percent particulate efficiency. In general, based on this and other information, FDA has determined that it was appropriate in order to protect the public health and safety to revise the April 3, 2020 EUA by making the following principal changes on May 7, 2020:
- Revising the eligibility criterion allowing authorization based on acceptable performance to standards documented by independent laboratory testing;
- Removing the ability of importers to apply for the EUA and directing manufacturers to provide a list of authorized importers; and
- Adding recognition of the Chinese National Medical Products Administration (NMPA) registration certification that can be verified by the FDA.
On June 6, 2020, the FDA reissued the EUA, by revising the Scope of Authorization to revise that authorized respirators listed in Appendix A will no longer be authorized if decontaminated, and also to revise the Scope of Authorization with respect to which jurisdictions are included in the criteria for eligibility in both EUAs, among other revisions.
Q: What steps is the FDA taking to ensure product quality?
A: Reissuing this EUA is just one example of FDA's vigilance and will help ensure quality products are available for HCPs by:
- Removing respirators from Appendix A that had been authorized based on the criterion for acceptable performance to standards documented by independent laboratory testing in the original letter of authorization dated April 3, 2020.
- Revising the EUAs to provide that respirators with a CE mark are eligible respirators since this marking indicates that the respirator has been assessed by an independent, accredited notified body, is found to meet high safety, health, and environmental protection requirements, and may be marketed in Europe.
- Increasing screening of imported respirators, and detaining shipments of products that NIOSH has listed on its website as not meeting the labeled performance criteria. The FDA will also be sampling respirators for NIOSH testing, to verify product filtration efficiency performance. These actions will help inform the FDA's decisions to allow entry of products meeting performance criteria, refuse products that do not, and identify situations where reconditioning of products for use only as face masks for source control (and not as PPE) is appropriate.
- Describing a process through which FDA may remove products from Appendix A based on concerns about their performance such that FDA has reason to believe they no longer meet the criteria for authorization.
Q: What is the FDA doing with firms whose products are removed from Appendix A, but have registered and listed with the FDA?
A. The EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China specifies that the firm does not have to register its establishment or list its device in order to distribute or import their device into the United States under this EUA. If the firm chose to register and list a device that was removed from the EUA, the FDA will not take further action to deactivate or remove the firm's registration. Registration and listing does not denote FDA approval, clearance, or authorization of a device or endorsement of a firm; rather, it simply provides the FDA with the location of a medical device establishment and devices manufactured at that location. This information is also highlighted on the Device Registration and Listing page.
As a reminder, the FDA does not issue Registration Certificates to medical device establishments.
Q: Does NIOSH plan on testing the respirators from firms that were removed from Appendix A but did not have NIOSH testing, and if so, when will the results be posted?
A: As explained in the reissued May 7, 2020, Letter of Authorization, manufacturers who had respirators that are no longer authorized have up to 45 days to have their respirators tested by NIOSH per the revised third criterion. Per the EUA, manufacturers should not send their respirators directly to NIOSH for testing. The FDA will sample respirators from already imported lots of respirators or once they arrive at a US port of entry. These final test results will be posted on the NIOSH website, Respirator Assessments to Support the COVID-19 Response.
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: Respirators authorized under this EUA are personal protective equipment that are intended for use by health care personnel in healthcare settings according to CDC's recommendations. Face masks, such as cloth facial coverings, are not considered personal protective equipment (PPE) and may be used by the public and health care personnel as source control only to help slow the spread of COVID-19 under the Face Mask umbrella EUA. Face masks intended for general use are authorized under the Face Mask (Non-Surgical) EUA when they meet certain criteria.
Q: Does a respirator 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. For information about face masks, including the FDA's enforcement policy with respect to face masks and respirators, please see the revised May 2020 Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)" Guidance. 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: 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: If your request for addition to Appendix A includes documentation that supports meeting eligibility criterion one (i.e., you hold one or more NIOSH approvals for other models of respirators) or criterion two (i.e., the model for which you are requesting emergency use authorization has a regulatory authorization under a jurisdiction that can be authenticated and verified by the FDA), the request will continue to be reviewed to determine if your respirator(s) meets one of these criteria. If your submission does not meet either of these criteria, as described in the May 7, 2020, Emergency Use Authorization, the request will not be granted and your respirator(s) will not be added to Appendix A.
As explained in the reissued EUA on May 7, 2020, demonstrating acceptable performance to applicable testing standards as documented by test reports no longer confers eligibility to be included in Appendix A of this EUA. As such, if your request was based on demonstrating acceptable performance to applicable test standards as documented by test reports and was not previously added to Appendix A, please submit a new request referring to your previous request and providing documentation to support eligibility based on eligibility criteria one or two. Such manufacturers will receive an email from the FDA notifying them of the EUA's reissuance which will explain the revisions to the eligibility criteria as set forth in the revised EUA.
Q: I am an importer and would like to request an EUA. What should I do?
A: As described in the reissued May 7, 2020 Emergency Use Authorization, only manufacturers may request addition to Appendix A under this EUA. Please contact the manufacturer and request that they submit the applicable information to FDA as explained in the EUA. If you will be an authorized importer for the manufacturer, please ensure that they list you as an authorized importer in their submission to FDA.
Q: What should health care personnel know about changes to the EUA and what actions should they take as a result?
A: Certain respirators that were previously on Appendix A are no longer authorized under the EUA and have been removed from Appendix A. Some of those respirators were tested by NIOSH and did not meet their labeled performance standard of a minimum particulate filtration efficiency of 95 percent. Manufacturers whose products were removed from Appendix A that did not have NIOSH testing performed previously but that submit new testing information from an FDA-collected sample of 30 respirators that has undergone a NIOSH assessment may be listed on Appendix A if they have acceptable test results (for example, all 30 respirators must meet greater than or equal to 95% filtration efficiency without exception) and if there are no other authenticity concerns.
A health care facility that has already purchased or is considering purchasing respirators previously listed on Appendix A should check the testing results from NIOSH to see if the respirator is included and should review the FDA's Letter to Health Care Providers for additional considerations. Health care facilities with respirators that failed the NIOSH testing may wish to consider several factors in deciding whether to use these products as face masks, including current need, inventory, facility practices, and acceptable uses. Health care facilities should be aware that face masks, including respirators that are relabeled as face masks, are not considered personal protective equipment (PPE) for health care personnel.
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.