On June 6, the Food and Drug Administration (FDA) issued updated Emergency Use Authorization (EUA) guidance, specific to the following personal protective equipment documents: Imported, non-National Institute for Occupational Safety and Health (NIOSH)-Approved Disposable Filtering Facepiece Respirators (FFRs).
- Non-NIOSH-Approved Disposable FFRs Manufactured in China
The FDA revised authorization criteria for Imported Non-NIOSH-Approved FFRs requires:
- Only authorized FFRs that conform to PPE directive 89/686/EEC (those placed in distribution before April 21, 2018) or those that conform to PPR Regulations European Union (EU) 2016/425 (those placed in distribution after April 21, 2018) as evidenced by a CE mark
- Added a criterion that authorizes disposable FFRs manufactured by entities that hold one or more NIOSH approvals, that have been verified by the FDA for FFRs, and that are produced by the NIOSH approval holder in accordance with the applicable standards of authorization in another country
- Decontaminated respirators with exhalation valves are no longer in the scope of products authorized under the EUA
- Added Conditions of Authorization requiring samples for testing when the requested by the FDA and prevents the distribution and shipments that fail testing
- Added Conditions of Authorization regarding printed materials, advertising, and promotions
The FDA will continue to review and authorize imported Non-NIOSH-Approved FFR submissions and requests. Authorized FFRs in this category will be added to Exhibit 1. For additional information, please see the Non-NIOSH respirator EUA FAQ.
The FDA revised the Scope of Authorization (Section II) and Conditions of Authorization (Section IV) for Non-NIOSH-Approved Disposable FFRs Manufactured in China. Respirators are eligible under this EUA if they meets any of the following criteria:
- The respirator is manufactured by an entity that holds one or more NIOSH approvals, that have been verified by FDA for FFRs, and that are produced by the NIOSH approval holder in accordance with the applicable standards of authorization in another country
- The respirator has:
- A registration certification, reflecting regulatory authorization, under the jurisdiction of the Chinese National Medical Products Administration (NMPA) and that is given by an appropriate provincial or municipal authority, and that has been authenticated and verified by FDA, or
- It conforms to PPE Directive 89/686/EEC (for those placed into distribution before April 21, 2019) or that conforms to PPE Regulation European Union (EU))2016/425 (for those placed into distribution after April 21, 2019), as evidenced by a CE mark, 8 and the CE mark has been authenticated and verified by FDA.
- The respirator was previously listed in Appendix A under the April 3, 2020 letter of authorization as an authorized respirator because it:
- Demonstrated acceptable performance to applicable standards as documented by test reports,
- Has had particulate filtration efficiency assessed by NIOSH using a modified version of NIOSH’s Standard Test Procedure (STP) TEB-APR-STP-0059 within 45 calendar days of the date of issuance of the May 7, 2020 letter, AND
- Has results of NIOSH testing that indicate a minimum and maximum filtration efficiency greater than or equal to 95 percent (see specific conditions exclusions to this criterion)
Manufacturers must demonstrate eligibility criteria by submitting a request and required documentation to the FDA. The process is outlined in the updated EUA for each criteria. The agency will notify the manufacturer of the inclusion of authorized respirator(s) and will add authorized respirators to Appendix A (list of authorized respirators). Additionally, the FDA has a list of respirator models from Appendix A, which no longer meet EUA eligibility criteria and are no longer authorized.
For additional information, please review the Non-NIOSH-Approved disposable FFRs EUA FAQs.
Visit the COVID-19 Resources for more information.
- COVID-19 Clinical Resource Guide
- COVID-19 guide to face masks and filtering facepiece respirators
- Guide to decontamination methods for filtering facepiece respirators
- FDA N95 Decontamination Systems Emergency Use Authorization Updates Guide
- FDA Personal Protective Equipment EUA Update Guide
- Guide to isolation and surgical gown selection