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.
Table of Personal Protective Equipment (PPE) EUAs
- 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
The table below includes informaitn about respirators authorized for emergency use by healthcare personal during the COVID-19 public health emergency.
Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Reissued June 6, 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). As mentioned in CDC’s strategies for optimizing respirator supply, other countries approve respirators according to country-specific standards. These devices are evaluated using methods similar to those used by NIOSH and are still expected to provide adequate protection for healthcare personnel. Non-NIOSH-approved FFRs manufactured in China that have been confirmed by FDA to meet the criteria under the EUA are included below in Appendix A.
As part of the government’s continuous quality assessment of these respirators, the FDA, working with CDC NIOSH, conducted additional assessments and found 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 to among other revisions, revise the third criterion for eligibility. Additionally, the FDA, in collaboration with CDC NIOSH, is increasing surveillance and sampling of all respirators imported from China – all respirator shipments from China that come into the U.S. will be subject to random sampling and testing by CDC 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, to among other changes, further revise the third eligibility criterion, revise the second eligibility criterion, and remove decontaminated respirators from the scope of authorized products such that authorized respirators listed in Appendix A will no longer be authorized if they are decontaminated. Further explanation of the revisions 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 June 7, 2020)
- Non-NIOSH Approved Disposable Filtering Facepiece Respirators Manufactured in China EUA FAQs
- Appendix A: Authorized Respirators, Non-NIOSH Respirators Manufactured in China (Updated June 7, 2020)
- Respirator Models No Longer Authorized
Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China (Updated: June 15, 2020)
The table below includes a list of non-NIOSH respirators authorized by this Umbrella EUA for emergency use during the COVID-19 public health emergency.
As stated in the EUA, authorized respirators should be used in accordance with 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.
These respirator models had been on the list of authorized respirators in Appendix A but no longer meet the EUA eligibility criteria and thus are no longer authorized. Note: As outlined in the EUA, a respirator model with a removal date of May 7, 2020 is eligible for authorization under the revised third criterion if it 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 May 7, 2020, and has results of NIOSH testing that indicate a minimum and maximum filtration efficiency greater than or equal to 95 percent. Respirators with removal dates after May 7, 2020 are not eligible for the revised third criterion. A respirator that meets the revised third criterion, or any of the other eligibility criteria in the EUA, is authorized and will be added to Appendix A as an authorized respirator once FDA confirms the eligibility criteria are met. Results from NIOSH’s testing are provided at: https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html
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 06/06/2020)
- Exhibit 1: Authorized Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (Updated April 14, 2020)
Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR) (Updated April 14, 2020)
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.
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.