Since April 8, 2020, seven states (in order of adoption: New Jersey, Rhode Island, New York, Maryland, Hawaii, Connecticut and Pennsylvania) have issued executive orders (“EOs”) requiring the wearing of face masks in various situations, ranging from being in a public place where close contact may be unavoidable, riding public transportation, working or shopping at an essential business or food service establishment, and going to a work site. In addition, the FDA has issued FAQs regarding the wearing of face coverings by employees in food and food production (i.e. workers in grocery stores, pharmacies, on farms, in food production, processing and retail settings). In the midst of these rapidly changing requirements that have the impact of requiring hundreds of thousands or even millions more masks to be available, we see business and innovation moving rapidly to answer the need. But, an overarching concern is liability. What if I give my workers masks… What if I make, import, distribute masks… and someone still gets sick? Or worse, dies?
On April 18, 2020, FDA issued a new Emergency Use Authorization (“EUA”), relating to non-surgical face masks with broad coverage and implications for recent industry participants manufacturing face masks.
The EUA applies to the broad class of non-surgical face masks used to cover a person’s nose and mouth, or, as stated in the EUA, “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, Letter of Authorization for Face Masks (non-surgical) (April 18, 2020), available here.
The FDA acknowledges in the EUA that “[t]here are many products marketed in the United States as ‘face masks’ that offer a range of protection against potential health hazards.” Generally, these types of masks are regulated as Class I devices that are exempt from premarket notification requirements.
NOTE that certain surgical masks, which are Class II devices that provide fluid barrier protection, are not covered under this EUA.
Following is a high-level summary of the scope and requirements of the EUA. For further details, see our detailed blog post on this EUA.
- Scope of Authorization: Use of face masks by members of the general public, including health care personnel in healthcare settings as personal protective equipment, to prevent the spread of SARS-CoV-2 during the COVID-19 pandemic.
- Labeling / Marketing: Must accurately describe product as a “Face Mask” and include a list of body contacting materials, should not be misleading, and should include recommendations that reduce risk of use (i.e. recommend against use in surgical setting, in a clinical setting where infection risk is high, etc.). The label should state that the face masks are not FDA approved and are sold under the EUA. No claims can be made that face masks are safe or effective for the “prevention or treatment of patients during the COVID-19 pandemic.”
- FDA Compliance: Most requirements are waived, but manufacturers/distributors must maintain records of entities to which they distribute masks and quantities distributed. Additionally, adverse events that they become aware of should be reported.
Manufacturers of authorized face masks that comply with the Conditions of Use summarized above do not need to take any additional action to qualify as a product covered by the EUA.
Under the PREP Act, codified at 42 USC §§ 247d-6d and 247d-6e, the manufacturer or distributor (including a business who gives its employees face masks) may have immunity under the PREP Act from any liability associated with the manufacture, testing, development, distribution, administration, and use of face masks covered by the EUA if the face masks are distributed (1) in connection with a federal agreement or contract, or (2) otherwise authorized in accordance with the public health and medical response of a specified governmental or health organization with authority to prescribe, administer, deliver, distribute, or dispense the face masks following the declaration of an emergency. In states where EOs are in place, or in industries covered by FDA requirements, the PREP Act may therefore limit a manufacturer’s or distributor’s potential liability. For more information on how the PREP Act applies in the current COVID-19 emergency and the scope of immunity, see our blog post.