The demand for face coverings has so outpaced the supply that health experts have released instructional videos demonstrating how Americans can craft their own face coverings.

Over the past week, the U.S. Food & Drug Administration (FDA) has taken a number of steps to enable manufacturers and distributors of face masks to more efficiently make their products available to the marketplace. FDA has accomplished this by establishing criteria that would allow manufacturers to bypass normally required (and often time-consuming) regulatory review.

While toilet paper shortages have made recent headlines, supplies of face masks—from nonmedical to high-grade N95 respirators—quickly dwindled once COVID-19 took hold in the United States. The demand for face coverings has so outpaced the supply that health experts—including the U.S. Surgeon General—have released instructional videos demonstrating how Americans can craft their own face coverings at home for nonmedical use.

To help alleviate concerns about supply shortages, FDA recently issued a number of guidance documents informing manufacturers and distributors (as well as consumers) about what types of face coverings may go to market without prior FDA approval—and under what circumstances. In the April 2020 Enforcement Policy for Face Masks and Respirators, applicable for the duration of the COVID-19 public health emergency, FDA described separate categories of face coverings and FDA’s enforcement policy as to each:

Face Masks, Face Shields and N95 Respirators Not Intended for a Medical Purpose

A wide range of face coverings are sold to the general public for nonmedical purposes; for instance, many are marketed to the general public for use in construction and other industrial settings. When face masks, face shields and N95 respirators are not intended for the diagnosis, cure, mitigation, treatment or prevention of a disease or other condition, they do not qualify as “devices” within the meaning of the Food, Drug and Cosmetic Act (FDCA). As such, FDA marketing authorization is not required for these products when they are not intended for a medical purpose; similarly, other requirements of the FDCA do not apply to manufacturers, importers and distributors of these products.

In deciding whether the products are indeed intended for a medical purpose, FDA has explained that it will consider whether their labels indicate that they are intended for use by healthcare professionals or in a healthcare facility and whether the products include any drugs, biologics, or antimicrobial or antiviral agents.

Face Masks Intended for a Medical Purpose That Are Not Intended to Provide Liquid Barrier Protection

For the duration of the COVID-19 public health emergency, FDA explained that, under certain conditions, the agency does not intend to object to distribution and use of face masks with or without face shields (not including respirators) intended for medical purposes, even when the product does not comply with certain normally applicable regulatory requirements (including prior submission of premarket notification under 510(k), registration and listing requirements, and others), provided that the products, among other things, (i) are not intended for any use that would create an undue risk in light of the public health emergency; and (ii) include labeling that accurately describes the product and the body-contacting materials (not to include a drug or biologic) and provides recommendations to reduce the risk of use (including recommendations against use in surgical settings or settings where high exposure to liquids or other hazardous materials may be expected).

Face Shields Intended for a Medical Purpose

As with the previous category of face masks, FDA does not intend to object to the distribution of face shields intended for medical purposes even without compliance with certain normally applicable regulatory requirements, provided that the face shields (i) include labeling that accurately describes the product and lists the body-contacting materials (not to include a drug or biologic); (ii) do not contain any materials that will cause flammability, or the products meets Class I or II flammability requirements (unless labeled with appropriate recommendations against use in presence of high-intensity heat source/flammable gas); and (iii) are not intended for any use that would create an undue risk in light of the public health emergency.

Surgical Masks Intended to Provide Liquid Barrier Protection

During the current public health emergency, FDA does not intend to object to distribution or use of surgical masks without compliance with certain normally applicable regulatory requirements provided that the products (i) meet fluid-resistance testing consistent with standard ASTM F1862l; (ii) meet Class I or II flammability requirements (unless labeled with appropriate recommendations against use in presence of high-intensity heat source/flammable gas); (iii) include labeling that accurately describes the product and include a list of body-contacting materials (not to include a drug or biologic); and (iv) are not intended for any use that would create an undue risk in light of the public health emergency.

Based on this guidance, on April 18, 2020, FDA issued an Emergency Use Authorization (EUA) limited to use of face masks by members of the general public—including healthcare personnel in healthcare settings as personal protective equipment—to cover the noses and mouth in accordance with CDC recommendations, as a means of preventing the spread of SARS-CoV-2, the virus behind COVID-19. The EUA makes clear that authorized face masks must meet a number of requirements, which closely track those identified on page 6 of the April 2020 guidance section on Face Masks Intended for a Medical Purpose that are Not Intended to Provide Liquid Barrier Protection.

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If you have any questions about this Alert, please contact Patrick C. Gallagher, Ph.D., Frederick R. Ball, Justin M. L. Stern, any of the attorneys in our Life Sciences and Medical Technologies Industry Group, any members of the COVID-19 Strategy Team or the attorney in the firm with whom you are regularly in contact.

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