FDA Enforcement Policy and Emergency Use Authorization (EUA) for Face Masks and Respirators

Introduction

On February 4, 2020, the Secretary of Health and Human Services (HHS) issued a declaration of a public health emergency related to the Coronavirus Disease 2019 (COVID-19) outbreak. In response, the U.S. Food and Drug Administration (FDA) has issued Enforcement Policy guidance and Emergency Use Authorization (EUA) letters to support response efforts in combating shortages of personal protective equipment (PPE).

On March 25, 2020, FDA issued the Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, which was subsequently reissued on April 2, 2020 and May 26, 2020. This guidance document is intended to help increase the availability of general use face masks, face shields, surgical masks, and respirators by waiving certain regulatory requirements.

The Enforcement Policy specifies that for face masks, face shields and surgical masks intended for a medical purpose, FDA is not enforcing the following regulatory requirements as long as certain performance and labeling requirements are met:

510(k) submission;

• Establishment Registration and Device Listing;

• Quality System Regulation (QSR) requirements;

• Reports or corrections and removals; and

• Unique Device Identification (UDI)

See Table 1 for a summary of these Enforcement Policy requirements.

Table 1 Requirements under Enforcement Policy

For respirators, as of the May 26, 2020 revision of the Enforcement Policy, FDA does not recommend using a product as a respirator unless it has been FDA-cleared, approved by the National Institute for Occupational Safety and Health (NIOSH) or authorized by FDA under an EUA as a respirator.

The EUA process allows FDA to authorize products for emergency use in order to facilitate the availability of such products during a public health emergency. In place of submitting a 510(k) to FDA for FDA-clearance or submitting an application to NIOSH for NIOSH-approval, the EUA pathway allows respirators to be authorized for use in healthcare settings by healthcare personnel (HCP) for the duration of the COVID-19 public health emergency. Over the past several months, FDA has issued five EUA letters pertaining to face masks, face shields and respirators, outlining the FDA’s requirements for these products to obtain an EUA.

On February 4, 2020, FDA issued the EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (excluding China), which was reissued on March 28, 2020, and June 6, 2020. This EUA makes certain filtering facepiece respirators (FFRs), including those that have been decontaminated by an authorized decontamination system, eligible for authorization if they have been designed, evaluated, and validated under performance standards used in other countries. This includes FFRs approved under applicable standards in Australia, Brazil, Europe, Japan, Korea, and Mexico, as well as those with a CE Mark that can be authenticated and verified by FDA. FFRs that are manufactured by entities that hold a NIOSH approval are also eligible under this EUA. In order to be authorized under this EUA, manufacturers and/or importers must send a request to FDA with certain information demonstrating eligibility as specified in the EUA letter, as well as comply with the conditions of authorization. Respirators authorized under this EUA are added to Exhibit 1.

On March 2, 2020, FDA issued the EUA for NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency, which was reissued on March 27, 2020 and March 28, 2020. This EUA authorizes all NIOSH-approved powered and non-powered air-purifying particulate filtering facepiece respirators and reusable respirators, including those devices that have passed the manufacturers’ recommended shelf life, and that have been decontaminated by an authorized decontamination system. Manufacturers with respirators eligible under this EUA, need only comply with the conditions of authorization as specified in the EUA letter and do not need to submit a request to FDA.

On April 3, 2020, FDA issued the EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China, which was reissued on May 7, 2020 and June 6, 2020. In order to obtain authorization, FFRs manufactured in China must be manufactured by an entity that holds a NIOSH approval, have a Chinese National Medical Products Administration (NMPA) certification, or have a CE mark that has been authenticated and verified by FDA. In addition, respirators that had previously been authorized under the April 3, 2020 EUA letter because they demonstrated acceptable performance standards, must be tested by NIOSH within 45 days of the May 7, 2020 EUA letter to demonstrate a filtration efficiency of at least 95 percent in order to remain authorized. Respirators that do not pass this additional testing, will no longer be authorized. In order to be authorized under this EUA, manufacturers must send a request to FDA with certain information to demonstrate eligibility as specified in the EUA letter, as well as comply with the conditions of authorization. Respirators authorized under this EUA are added to Appendix A. Respirators that are no longer authorized as a result of the revised eligibility criteria are added to the list of Respirator Models Removed from Appendix A.

On April 9, 2020, FDA issued the EUA for Face Shields, which was reissued on April 13, 2020. This EUA authorizes the use of standalone face shields for use by HCP as PPE that meet certain labeling requirements comparable to the guidelines set forth in the FDA Enforcement Policy discussed previously. These labeling requirements include but are not limited to, no labeling stating that the face shield alone will prevent infection from microbes or viruses, or that it is effective against radiation protection. Manufacturers of eligible face shields do not need to take any action for authorization other than comply with the conditions of authorization, as specified in the EUA.

Lastly, on April 18, 2020, FDA issued the EUA for Face Masks (Non-Surgical), which was reissued on April 24, 2020. This EUA authorizes the use of face masks as source control by the general public and HCP. Source control refers to the use of a face mask to contain an individual’s respiratory secretions to help prevent transmission from individuals who may or may not have symptoms of COVID-19. Face masks under this EUA must meet certain labeling requirements, including but not limited to, no labeling pertaining to uses for particulate filtration and infection prevention or reduction, which are comparable to the guidelines set forth in the FDA Enforcement Policy discussed previously. Manufacturers of such face masks do not need to take any action for authorization other than comply with conditions of authorization specified in the EUA.

For face masks and respirators that do no fall within the scope of these EUAs, FDA is interested in interacting with manufacturers for additional device-specific EUAs. This may include manufacturers of masks and respirators that are not currently legally marketed in the U.S. as well as manufacturers who have not previously manufactured masks or respirators. FDA recommends manufacturers send any available information to support an EUA request to FDA in order to determine whether the device can be authorized under an EUA.

For all of the EUAs discussed, FDA is waiving Good Manufacturing Practice (GMP) requirements including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of the authorized respirators. In addition, Establishment Registration and Device Listing is not required for devices under EUA.

It is important to know that the Enforcement Policy and EUAs are intended to remain in effect only for the duration of the public health emergency related to COVID-19. Therefore, it is essential to pursue the appropriate FDA regulatory pathway (e.g. 510(k)) in conjunction with the EUA process. That way, devices under Enforcement Policy or EUA can remain on the market after the public health emergency is over.