The U.S. Food and Drug Administration (FDA) recently unmasked new guidance surrounding distribution of surgical masks. As a brief recap, on April 16, 2020, the FDA issued an Emergency Use Authorization (EUA) authorizing the use of face masks for use by members of the general public, including healthcare personnel, in healthcare settings as personal protective equipment. Notably when this EUA was revised on April 24, surgical masks were excluded from the scope of authorization. In that EUA, the FDA stated that surgical masks are regulated under 21 CFR 878.4040 as Class II devices requiring a 510(k) premarket notification.

On March 25, 2020, the FDA initially published its Enforcemeant Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Enforcement Policy). It has undergone several revisions, and the latest revised Enforcement Policy is from May 2020. The current Enforcement Policy states that the FDA will not object to the distribution and use of surgical masks, removing the previous requirement of 510(k) premarket notification, provided the masks comply with the FDA's policy provided in the guidance, described later in this alert.

On August 5, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for certain disposable, single-use surgical masks. The official authorization can be located here. This EUA will be effective until the FDA's declaration that circumstances no longer justify authorization. A potential reason for the FDA providing an EUA for surgical masks is likely to grant immunity under the Public Readiness and Emergency Preparedness Act (PREP Act).

On August 18, 2020, the FDA held a webinar where they further clarified their Enforcement Policy guidance pertaining to surgical masks. The webinar, while consistent with the Enforcement Policy, emphasized that an EUA is not necessary for surgical masks, and that surgical masks can enter the stream of commerce without further scrutiny by the FDA, provided the masks comply with their Enforcement Policy.

This alert provides an overview of the surgical mask EUA.

Overview

On August 5, in response to concerns relating to the insufficient supply and availability of disposable, single-use surgical masks, the FDA issued this EUA to protect the public health and safety under Section 564(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Manufacturers currently have three different options to market their surgical face masks. The first option allows manufacturers to proceed with the standard 510(k) Premarket Notification. This option would permit manufacturers to continue distributing masks after the pandemic has ended. The second option is to follow the guidance listed in the Enforcement Policy, where the FDA would not object to distribution as long as the masks are in compliance with the recommendations. The third option, discussed more in depth below, is to pursue an EUA for the surgical masks. These options are not mutually exclusive, and manufacturers can pursue them concurrently.

Scope of Authorization—Excluded Surgical Masks

A. Excluded Surgical Masks

A surgical mask is a mask that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. This EUA specifically excludes any surgical mask that:

1. has been cleared by the FDA (either through 510(k) submission or otherwise);
2. is manufactured in China; and
3. includes drugs, biologics, nanoparticles, or antimicrobial/antiviral agents.

B. Performance Standards

A surgical mask that is not excluded will be authorized if it meets the following performance standards:

1. Fluid resistance requirements (liquid barrier performance) consistent with ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity);
2. Flammability performance consistent with the definition of either a Class 1 or Class 2 textile in 16 CFR Part 1610;
3. Particulate filtration efficiency requirements consistent with ASTM F2100: Standard Specification for Performance of Materials Used in Medical Face Masks;
4. Air flow resistance (i.e., breathability) requirements with an acceptance criterion of <6 mm H2O/cm2 for differential pressure (delta P) testing consistent with ASTM F2100: Standard Specification for Performance of Materials Used in Medical Face Masks for those masks composed of four or more layers; and
5. The materials of manufacture are either 1) non-cytotoxic, non-irritating and non-sensitizing consistent with the recommendations in FDA's guidance, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process'" or 2) conform to the following biocompatibility standards:
   1. ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
   2. ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
   3. ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.

Labeling Requirements

To be authorized under this EUA, the labeling of the surgical masks must:

1. describe the product as a disposable, single-use surgical mask. The labeling must include a list of the body contacting materials (which does not include any drugs, biologics, nanoparticles, or antimicrobial/antiviral agents);
2. state that the product is not intended to replace the need for FDA-cleared surgical masks or FDA-cleared or authorized respirators;
3. state that surgical masks are not intended to provide protection against pathogenic biological airborne particulates and are not recommended for use in aerosol generating procedures and any clinical conditions where there is significant risk of infection through inhalation exposure;
4. not include statements that would misrepresent the product or create an undue risk in light of the public health emergency. For example, the labeling must not include any express or implied claims for: 1) reuse, 2) antimicrobial or antiviral protection or related uses, 3) infection prevention, infection reduction, or related uses, or 4) viral filtration efficiency; and
5. in addition to the above requirements, the surgical masks must be accompanied by the Fact Sheet for Healthcare Personnel: Emergency Use of Authorized Disposable, Single Use Surgical Masks During the COVID-19 Pandemic.

Authorization Process

In order to be added on the FDA's Appendix A, surgical masks authorized by this Umbrella EUA—the surgical mask must not be excluded from the scope of authorizations and conform to the performance standards listed above. If the FDA has reason to remove a product that it believes no longer meets the Scope of Authorization or Conditions of Authorization listed in the EUA, the FDA will provide the manufacturer 24 hours advance notice and may work with the manufacturer to resolve that issue.

Manufacturers may request the inclusion of any surgical mask model in Appendix A by submitting a request to the FDA with the subject line "Surgical Masks EUA" to CDRH-nondiagnosticEUA-templates@fda.hhs.gov. They must provide the following information in their cover email:

1. manufacturer contact information, name and address of business, email address, 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 (if any);
2. a copy of the product labeling;
3. an estimate of the number of surgical masks you are planning to market and distribute during the public health emergency;
4. a summary of the evidence demonstrating that the surgical mask meets the above criteria, including test reports; and
5. a list of authorized distributor(s) and/or authorized importer(s), including contact information (name, address, contact person, phone number, and email).

Distributing Surgical Masks Without an EUA

According to the FDA's current Enforcement Policy, and emphasized in the FDA's August 18th webinar, you do not need an EUA or 510(k) premarket clearance for surgical masks if you are in compliance with the Enforcement Policy during the Covid-19 pandemic. In order to be in compliance with the Enforcement Policy:

1. the product must meet fluid resistance testing (liquid barrier performance) consistent with standard ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity);
2. the product must meet Class I or Class II flammability requirement per 16 CFR 1610 (unless labeled with a recommendation against use in the presence of high intensity heat source or flammable gas); and
3. the product must include labeling that accurately describes the product as a surgical mask and includes a list of the body contacting materials (which does not include any drugs or biologics).

It is important to note that the labeling requirements in the Enforcement Policy do not state uses for antimicrobial, antiviral, or related uses for infection protection or reduction. The labeling also does not permit particulate filtration claims.

Obtaining an EUA for a surgical mask, while not necessary at this time, grants the manufacturer immunity from liability under the PREP Act.