By Denise Bense and Karl Neumann

Law360 (April 13, 2020, 5:47 PM EDT) --

Denise Bense

Karl Neumann

Persistent headlines keep reminding us that the U.S. has run out of masks. Health officials have implored retailers to practice corporate generosity and donate what is left on their shelves. The surgeon general is asking lay people not to buy or hoard them. And the shortage has led to investigations into what some are calling unethical price-gouging.

The U.S.' strategic national stockpile includes roughly 12 million medical-grade N95 masks and 30 million surgical masks.[1] That is only approximately 1% of the estimated 3.5 billion that the U.S. Department of Health and Human Services estimates would be necessary if the COVID-19 pandemic lasts over a year.[2] With now more than 550,000 confirmed cases in the U.S. alone,[3] the shortage presents yet another obstacle for health care workers in the fight against the virus.

Ascending from this shortage has been a grassroots-meets-industry mobilization to help wage war on the virus. Lay people and manufacturers of just about every type of business are lending assistance to create masks. Companies that once made mattresses, shoes, apparel and many other products are now turning efforts toward the manufacturing face masks.[4] Even a business that manufactures sports jerseys for professional athletes is now making masks using the same jersey material from its products.

A recurring question from manufacturers wanting to assist in these efforts is, "What regulations exist and to what extent are they being enforced?" In light of this and an effort to increase availability of masks, the U.S. Food and Drug Administration recently issued an updated guidance policy for face masks and respirators.[5] At its core, the policy's purpose is to ease compliance requirements that manufacturers would typically have to meet before distributing masks.

The guidance remains in effect for the duration of the public health emergency as declared by HHS.[6] For those businesses wanting to start manufacturing face masks, understanding the FDA's regulation of face masks generally and in light of recent circumstances will prove helpful in manufacturing efforts.

When is a face mask a medical device?

There are many types of face masks out on the market used in different industries and for varying purposes. The FDA regulates face masks when they meet the definition of a device under Section 201(h) of the Federal Food, Drug and Cosmetic Act.

A face mask is a device subject to regulation when it is intended for a medical purpose, or otherwise "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease."[7] The masks that are subject to regulation cover a range of masks and include masks used by the general public in public health emergencies,[8] to more robust masks like surgical masks with antiviral agents.[9]

In determining whether the products are intended for a medical purpose, the FDA will consider whether the mask (1) is labeled or intended for use by a health care professional; (2) is labeled or intended to be used in a health care-associated environment; and (3) includes any drugs, biologics, anti-microbial or anti-viral agents.[10] This list is nonexhaustive.  

When face masks are not intended for medical use, they are not classified as a medical device and, therefore, neither FDA device marketing authorization nor the requirements under the Federal Food, Drug and Cosmetic Act apply.

The FDA is lifting typical production and distribution requirements.

In light of the ongoing need for masks, the FDA is suspending[11] enforcement of premarket requirements for certain face masks: the "FDA does not intend to object to individuals' distribution and use of improvised PPE when no alternatives, such as FDA-cleared masks or respirators, are available."[12]

More specifically, the FDA is waiving regulatory requirements, including submission of premarket notification under the 510(k) process, registration and listing requirements, quality system regulation requirements, reports or corrections and removals, and unique device identification requirements.[13]

The major caveat is that any face mask manufactured cannot "create an undue risk in light of the public health emergency."[14] For face masks intended for medical purposes, but not intended to provide liquid barrier protection, no undue risk is seen where:

• The product includes accurate labeling describing the product as a face mask. For example, the face mask should not be labeled as a surgical mask.

• The labeling includes a list of the material that makes contact with the body. The contacting materials may not include any drugs or biologics.

• The labeling makes recommendations that would sufficiently reduce any risks of usage. For example, it could include a recommendation against use in a surgical setting or against use in environments with increased exposure to fluids or high intensity heat sources.

• The product is not intended for any use that would create an undue risk in light of the public health emergency. For example, the labeling should not include that the mask can be used for antimicrobial or antiviral protection or be used for infection prevention.

The FDA takes a similar approach with surgical masks that are intended to provide liquid barrier protection. Surgical masks are Class II devices that cover the user's nose and mouth while also providing a barrier to fluids and particulate materials. They are also tested for flammability and biocompatibility. The FDA is lifting the same requirements as those noted above for masks not intended to provide liquid barrier protection.[15]  

Such devices are not believed to create an undue risk under similar circumstance to above with a few additional variables:

• The product meets fluid resistance testing consistent with ASTM F1962.

• The mask meets Class I or Class II flammability requirements pursuant to Title 16 of Code of Federal Regulations Part 1610. This does not apply if the mask is labeled with an explicit recommendation against use in the presence of high-intensity heat sources.  

• The product includes accurate labeling describing the product as a surgical mask.

• The product includes a list of materials contacting the body, which do not include drugs or biologics within the materials.

• The product is not intended for any use that would create an undue risk in light of the public health emergency.

Similarly, the FDA states it does not intend to object to companies importing and distributing alternative respirators identified in CDC recommendations.[16] The Centers for Disease Control and Prevention recommends use of alternative face masks approved under standards used in other countries when FDA-cleared or National Institute for Occupational Safety and Health-approved N95 respirators are unavailable.[17]

However, the FDA notes that because it cannot confirm the authenticity of any alternative respirators from abroad, it recommends that people take appropriate steps to verify the authenticity of the products before importing them.

The FDA is seeking collaboration, and companies should be familiar with compliance.

In the recent guidance update, the FDA is now welcoming the opportunity to work with any manufacturer with interest in manufacturing masks and respirators — even if the manufacturer has no previous experience in medical device manufacturing. For example, the FDA would like to work collaboratively with manufacturers on device-specific emergency use authorizations.

Likewise, the FDA guidance also addresses the reprocessing of otherwise disposable N95 particulate filtering facepiece respirators (or other similar filtering facepiece respirators). Under normal circumstances, a reprocessor would need to obtain 510(k) clearance to reprocess single-use medical devices. The FDA is seeking input from companies to facilitate the safe reuse and conservation of such devices.

The FDA recognizes that because of the short supply of masks, companies need to act quickly despite not being well-versed in mask construction and regulation. The FDA's guidelines will help increase the supply of alternative face masks during the ongoing pandemic. Worth noting, the FDA's guidance does not establish any enforceable rights or responsibilities — i.e., it is merely the FDA's current thinking and any guidance are at most suggestions or recommendations.

That said, companies attempting to manufacture or distribute face masks should not only review the entirety of the FDA's guidance but also be familiar with other FDA compliance measures that may still be applicable. The FDA's guidance document is not necessarily an exhaustive list of what should be done when manufacturing masks, and a full understanding of FDA regulations is required.

So long as the masks are not created with undue risk, efforts by various companies will serve as another vehicle toward preserving the workforce that is on the front lines in the fight against the virus.

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Denise Bense is a member and Karl Neumann is an associate at Cozen O'Connor.

The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firms, their clients, or any of its or their respective affiliates. This article is for purposes of general information and is not intended to be and should not be taken as legal advice.

[1] Abby Goodnough, Some Hospitals Are Close to Running Out of Crucial Masks for Coronavirus (March 9, 2020), https://www.nytimes.com/2020/03/09/health/coronavirus-n95-face-masks.html. 

[2] Dep't of Health and Human Servs., HHS to Procure N95 Respirators to Support Healthcare Workers in COVID-19 Outbreaks (March 4, 2020), https://www.hhs.gov/about/news/2020/03/04/hhs-to-procure-n95-respirators-to-support-healthcare-workers-in-covid-19-outbreaks.html.

[3] Centers for Disease Control and Prevention, Cases in U.S. (Updated April 13, 2020), https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html.

[4] Ingrid Schmidt, Fashion Brands Are Making Face Masks, Medical Gowns for the Coronavirus Crisis, Los Angeles Times (March 24, 2020), https://www.latimes.com/lifestyle/story/2020-03-24/fashion-brands-face-masks-medical-surgical-gowns-coronavirus; Nicole Yang, New Balance is Working to Manufacture Facial Masks During Coronavirus Pandemic (March 28, 2020), https://www.bostonglobe.com/2020/03/28/sports/new-balance-is-working-manufacture-facial-masks/.

[5] See U.S. Food and Drug Admin., Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised), Guidance for Industry and Food and Drug Administration Staff (April 2020), https://www.fda.gov/media/136449/download.

[6] On January 31, 2020, the Secretary of Health and Human Services, Alex Azar II, determined that a nationwide public health emergency began on January 27, 2020. Dep't of Health and Human Services, Secretary Azar Declares Public Health Emergency for United States for 2019 Novel Coronavirus (January 31, 2020), https://www.hhs.gov/about/news/2020/01/31/secretary-azar-declares-public-health-emergency-us-2019-novel-coronavirus.html.

[7] Section 201(h) of the Food, Drug & Cosmetic Act.

[8] 21 CFR 880.6260 (General Hospital and Personal Use Devices).

[9] 21 CFR 878.4040 (Surgical Apparel).

[10] See U.S. Food and Drug Admin., Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised), Guidance for Industry and Food and Drug Administration Staff (April 2020), https://www.fda.gov/media/136449/download.

[11] Id.

[12] Id.  

[13] Id.

[14] Id.

[15] The FDA's updated guidance also addresses face shields for medical use. While outside the scope of this article, face shields are Class I devices and exempt from premarket notification requirements under the 510(k) process. See 21 CFR 878.4040.

[16] See Centers for Disease Control and Prevention, Strategies for optimizing the Supply of N95 Respirators During the COVID-19 Response, cdc.gov/coronavirus/2019-ncov/hcp/checklist-n95-strategy.html ("Use alternatives to N95 respirators where feasible (e.g.,other disposable filtering facepiece respirators, elastomeric respirators with appropriate filters or cartridges, powered air purifying respirators)").

[17] Notably, even state health departments are releasing interim guidance on alternative facemasks Minnesota Dep't of Health, Interim Guidance on Alternative Facemasks (March 27, 2020), https://www.health.state.mn.us/diseases/coronavirus/hcp/masksalt.pdf.

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