美国EUA豁免-Personal Protective Equipment EUAs-豁免防疫应急物资更新20210115

Personal Protective Equipment refers to protective clothing, helmets, gloves, face shields, goggles, respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness.

To help address concerns about availability during the COVID-19 pandemic, the FDA has issued EUAs for certain PPE products including face shields, other barriers, and respiratory protective devices such as respirators. Additionally, the FDA has issued recommendations and policies about PPE which can be found here: Recent Final Medical Device Guidance Documents.

Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA, including an Interactive Review Template For Non-IVD Products. Additionally, the FDA has posted a Surgical Masks EUA Template for Addition to Appendix A of the Surgical Mask Umbrella EUA.

Table of Personal Protective Equipment (PPE) EUAs

• Umbrella EUA for Surgical Masks

• N95 and Other Respirators EUAs

• Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs)

• Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs)

• Face Shields and Other Barrier EUAs

Umbrella EUA for Surgical Masks

On August 5, 2020, the FDA issued an umbrella emergency use authorization (EUA) for certain disposable, single-use surgical masks in response to concerns relating to insufficient supply and availability of such masks. This EUA authorizes the emergency use of surgical masks that meet certain performance requirements for use in healthcare settings by health care personnel as personal protective equipment to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic. Surgical masks that have been confirmed by FDA to meet the criteria under the EUA are included below in Appendix A as authorized surgical masks.

• EUA Letter of Authorization - Umbrella EUA for Surgical Masks 

• Fact Sheet for Healthcare Personnel

• Appendix A: Authorized Surgical Masks 

The Surgical Masks EUA Template for Addition to Appendix A can be used to provide the information requested in the EUA to the FDA.

Appendix A: Authorized Surgical Masks

The table below includes a list of surgical masks authorized by this Umbrella EUA for emergency use during the COVID-19 public health emergency.

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N95 and Other Respirators EUAs (including EUAs for NIOSH-Approved N95s and imported respirators)

The table below includes information about respirators authorized for emergency use by healthcare personal during the COVID-19 public health emergency.

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Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Reissued October 15, 2020)

On April 3, 2020, the FDA issued an umbrella EUA for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the National Institutes of Occupational Safety and Health (NIOSH). Respirator models authorized by this EUA are listed in Appendix A and are authorized for emergency use by healthcare personnel in healthcare settings in accordance with CDC recommendations. Summaries of FDA’s reissuances of this EUA follow.

As part of the federal government's continuous quality assessment of these respirators, the FDA, working with CDC’s NIOSH, conducted additional assessments and found that NIOSH’s data indicated that some of the respirators authorized under the April 3, 2020 EUA did not meet the expected performance standards. In response, the FDA revised and reissued the EUA on May 7, 2020, including revising the third eligibility criterion such that all respirators that were previously authorized only under that criterion were no longer within the scope of authorization and were accordingly removed from Appendix A unless the respirator model was authorized under one of the remaining eligibility criterion in the May 7th letter. Additionally, the FDA, in collaboration with CDC’s NIOSH, increased surveillance and sampling of all respirators imported from China. All respirator shipments from China that come into the U.S. are subject to random sampling and testing by CDC’s NIOSH to determine whether the respirator meets the expected particulate filtration standards.

On June 6, 2020, the FDA further revised the Scope of Authorization of this EUA, including, among other changes, further revision to the eligibility criteria to provide additional specificity regarding the jurisdictions eligible for review and to remove decontaminated respirators from the scope of authorized products such that authorized respirator models listed in Appendix A are not authorized if they are decontaminated.

On October 15, 2020, the FDA reissued the EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators manufactured in China to authorize for emergency use only those respirators listed in the EUA’s Appendix A as of the date of this reissuance. As of October 15, 2020, this EUA no longer includes the three eligibility criteria that were included in the previous June 6, 2020 authorization letter, meaning the FDA will no longer be reviewing requests and adding new respirator models to Appendix A based on those criteria. *Further explanation of the current EUA can be found in the Frequently Asked Questions (FAQs) about Non-NIOSH-Approved Filtering Facepiece Respirators.

• EUA Letter of Authorization - Umbrella EUA: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (Reissued October 15, 2020)

• Non-NIOSH Approved Disposable Filtering Facepiece Respirators Manufactured in China EUA FAQs

• Appendix A: Authorized Respirators, Non-NIOSH Respirators Manufactured in China (Updated October 15, 2020)

• Respirator Models No Longer Authorized (Updated October 15, 2020)

* Please note that the Appendix A list may be updated periodically to reflect administrative changes (for example, inclusion of a link to the instructions for use) or respirator model removal.

Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China (Updated with Administrative Changes or Respirator Model Removals: October 15, 2020.)

The table below includes a list of non-NIOSH-approved respirator models manufactured in China that are authorized by this Umbrella EUA for emergency use during the COVID-19 public health emergency.

As stated in the EUA, authorized respirators are authorized for use by healthcare personnel in healthcare settings in accordance with the CDC's recommendations. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage: Strategies for Optimizing the Supply of N95 Respirators.

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Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (Reissued June 6, 2020)

On March 24, 2020, the FDA issued an umbrella EUA for certain imported disposable filtering facepiece respirators (FFRs) that are not approved by the National Institute for Occupational Safety and Health (NIOSH) and that meet criteria as described in the EUA. Under this EUA, authorized respirators, which are listed in Exhibit 1, are authorized for use in healthcare settings by healthcare personnel when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the Coronavirus Disease 2019 (COVID-19) outbreak.

On March 28, 2020, to further address the shortage of disposable FFRs, the FDA determined it was necessary to reissue the March 24, 2020 letter in order to amend the Scope of Authorization to additionally authorize the use of authorized respirators that have been decontaminated pursuant to the terms and conditions of an authorized decontamination system.

The FDA continues to be vigilant and take prompt action on imported, non-NIOSH approved respirators to ensure health care personnel receive adequate protection. On June 6, 2020, the FDA again revised this EUA to revise the scope concerning the decontamination of respirators with exhalation valves, and also revised the Scope of Authorization with respect to which jurisdictions are included in the second criterion for eligibility, among other revisions.

• EUA Letter of Authorization - Umbrella EUA Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (Reissued June 6, 2020)

• Exhibit 1: Authorized Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (Updated January 15, 2021)

Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR) (Updated January 15, 2021)

The table below includes a list of authorized non-NIOSH-approved disposable filtering facepiece respirators (FFRs) authorized under this Umbrella EUA for emergency use in healthcare settings by healthcare personnel (HCP) when used in accordance with CDC recommendations. For the most current CDC recommendations on optimizing respirator use, please visit CDC's webpage: Strategies for Optimizing the Supply of N95 Respirators.

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Face Shields and Other Barrier EUAs

On May 1, 2020, the FDA issued an umbrella EUA for emergency use of protective barrier enclosures by healthcare providers (HCP) when caring for or performing medical procedures on patients who are known or suspected to have COVID-19 in healthcare settings to prevent HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to personal protective equipment (PPE). The authorization of a device for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act, be revised or revoked when the criteria under section 564(b)(1) of the Act no longer exist, the criteria under section 564(c) of the Act for issuance of such authorization are no longer met, or other circumstances make such revision or revocation appropriate to protect the public health or safety.

On August 20, 2020, based on FDA's continued review of the scientific evidence available, the FDA has become aware of information that supports a determination to revoke the umbrella EUA on the grounds that the criteria under section 564(c) of the Act for issuance of an EUA are no longer met (see section 564(g)(2)(B)). Under section 564(c) of the Act, an EUA may be issued only if FDA concludes “that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that: (A) the product may be effective in diagnosing, treating, or preventing ---(i) such disease or condition […]; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product […].” In addition, FDA has determined that revocation is appropriate to protect the public health or safety (see section 564(g)(2)(C) of the Act), and that individualized consideration of each EUA request for protective barrier enclosures would better protect the public health.

Face shields and other barriers are a type of PPE intended to protect the user from bodily fluids, liquid splashes, or potentially infectious materials. Availability of certain PPE are an integral part of routine patient care during the COVID-19 pandemic. The table below includes authorization information about the use of authorized face shields and other barriers for use during the COVID-19 public health emergency.

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