The U.S. Food and Drug Administration (FDA) issued on April 18, 2020, an Emergency Use Authorization (EUA) for manufacturers and distributors of face masks in response to the ongoing efforts for prevention of the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As discussed below, in issuing this EUA, the FDA is effectively allowing manufacturers and distributors to address well-publicized concerns relating to national personal protective equipment (PPE) shortages for face masks, but only for the general public and health care personnel (HCP) within a specified scope.

Background

During the COVID-19 pandemic, FDA has been actively pursuing a multitude of actions to address this novel respiratory virus. The EUA issued on April 18 is one of many that FDA has issued since the initial declaration of a public health emergency by the Secretary of the Department of Health and Human Services. FDA notes, for diagnostics alone, as of April 20, 2020, that it has worked with more than 340 test developers, has issued 41 individual EUAs for test kit manufacturers and laboratories, has authorized 16 tests for high-complexity molecular-based laboratory developed tests, and has been notified that more than 210 laboratories are testing. FDA continues to issue daily updates on its progress during the pandemic.

The April 18, 2020, EUA addresses “concerns relating to insufficient supply and availability of face masks for use by members of the general public, including health care personnel (HCP) in healthcare settings as personal protective equipment (PPE), to cover their noses and mouths, in accordance with Centers for Disease Control and Prevention (CDC) recommendations….”

FDA is clear that “face mask” does not include surgical masks, nor products that imply “antimicrobial or antiviral protection” nor claims “for use such as infection prevention or reduction,” or “for particulate filtration.” FDA notes, “[a] face mask is a device, with or without a face shield, that covers the user’s nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. It includes cloth face coverings. It may be for single or multiple uses, and if for multiple uses it may be laundered or cleaned.” FDA regulates face masks as a medical device, under 21 C.F.R. Section 878.4040, when intended for medical purposes (non-surgical masks). Surgical masks are outside the scope of the April 18, 2020 EUA. Surgical masks “provide a physical barrier to fluids and particulate materials and are regulated under 21 CFR 878.4040 as class II devices requiring premarket notification.”

The EUA defines HCP as “all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air.”

FDA authorizes manufacturers and distributors to “make face masks available with labeling that includes a description of the product as a face mask, including a list of the body contacting materials (which does not include any drugs or biologics).” FDA provides language that includes that the authorized manufacturers and distributors of these products shall not label the product “1) as a surgical mask, to provide liquid barrier protection, 2) for use in any surgical setting or where significant exposure to liquid, bodily or other hazardous fluids, may be expected, 3) for use in a clinical setting where the infection risk level through inhalation exposure is high; 4) for use in the presence of a high intensity heat source or flammable gas, 5) for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses, or 6) to include particulate filtration claims.”

In addition, labeling is to be provided to each end user in hard copy or via an alternative format with instructions on how to access and contain cleaning and/or disinfection processes (if applicable). FDA expects manufacturers to maintain records, processes for inventory control, and have a process in place for reporting of adverse events as required under 21 C.F.R. Part 803. FDA maintains that all printed materials, including promotional items, must adhere to the EUA and shall not represent or suggest the product “is safe or effective for the prevention or treatment of patients during the COVID-19 pandemic.”

Commentary

In issuing this EUA, FDA is allowing manufacturers and distributors to address well-publicized concerns relating to national PPE shortages for face masks, but only for the general public and HCP within a specified scope. FDA is not authorizing manufacturers or distributors to make claims for prevention or treatment, to offer surgical masks, or to offer face masks that include drugs or biologic materials. While FDA is waiving certain requirements, it expects transparent labels, inventory controls, record management, and event reporting for any manufacturer or distributor considering the conditions of the EUA. Companies currently aware of, or subject to, the requirements of these various Parts of 21 C.F.R. (e.g., 21 C.F.R. Part 820, Part 830, and Section 801.20) should find this EUA beneficial in addressing the current pandemic. Companies that are unfamiliar with FDA regulations for devices should consider the regulatory framework, and the scope of the EUA and should determine if compliance, under these specified conditions, is achievable. The EUA will be effective until the FDA determines that the authorization can be terminated or revoked.