In response to increased concerns regarding insufficient personal protective equipment (“PPE”), the FDA recently issued an Emergency Use Authorization (“EUA”) applicable to face masks for use by both the general public and health care personnel. Significantly, the EUA defines a face mask broadly as a device, including “a cloth face covering,” “with or without a face shield, that covers the user’s mouth,” that “may or may not meet fluid barrier or filtration efficiency levels,” and that may be for “single or multiple uses.”
The EUA has two particularly important effects for manufacturers and distributors of face masks, so long as the masks conform to the EUA’s labeling requirements discussed below: (1) Mask manufacturers and suppliers who otherwise meet the requirements of recent Department of Health and Human Services (“HHS”) PREP Act Declarations, including distribution in accordance with a government contract or public health response, may be afforded the liability immunity granted to manufacturers and distributors of COVID-19 countermeasures produced and supplied under an Emergency Use Authorization; and (2) Mask manufacturers and suppliers do not need to meet stringent manufacturing standards, including the quality system requirements under 21 CFR 820, and labeling requirements broader than those discussed below.
HHS recently issued PREP Act Declarations that grant liability immunity to manufacturers and suppliers of COVID-19 countermeasures which include, in relevant part, a drug, device, or biological product authorized for emergency use with respect to COVID-19 under an EUA. In the context of face masks, prior to the EUA, the PREP Act Declarations limited immunity to manufacturers of FDA-approved or cleared, and NIOSH-approved, surgical masks and respirators only. In light of the EUA, however, any face mask that covers an individual’s nose and mouth and that is manufactured and distributed in accordance with the PREP Act Declarations and the EUA would qualify as a device authorized for emergency use, and manufacturers and distributors of such a product would thus enjoy liability immunity to claims of bodily injury during the period of time the EUA remains in effect.
Critically, to be entitled to immunity under the PREP Act Declarations, the masks must either be distributed in connection with a federal contract or agreement, or “in accordance with the public health and medical response” of the relevant governmental authority.
Accordingly, though the EUA expands the types of masks that may be entitled to immunity, manufacturers, and distributors of masks distributed outside of federal, state, or local contracts or public health response efforts may be unable to claim immunity under the express terms of the PREP Act Declarations. These concerns may be particularly relevant to those manufacturers and suppliers who, for example, distribute products only to privately funded health care facilities.
Further, manufacturers and distributors of these masks must also meet the labeling and promotional material requirements set forth in the EUA to enjoy immunity. Specifically, the EUA requires that labeling must include a description of the product as a face mask, and must list all body-contacting materials (which does not include drugs or biologics). The EUA also contains a host of statements that cannot be included in labeling, which can be generally summarized as representations of the product: (1) as a “surgical mask”; (2) for use in surgical or clinical settings; (3) for antimicrobial or antiviral protection, or infection prevention; and (4) for use in the presence of high-intensity heat or flammable gas. Manufacturers must have a process in place for reporting adverse events under 21 CFR Part 803. While distributors need not have an adverse event reporting process in place, if their upstream manufacturers do not have such a process in place, the distributors may not be entitled to immunity.
With respect to advertising and promotional materials, the EUA specifies that such materials must largely conform to the labeling requirements described above, and must not represent or suggest that the product is safe or effective for the treatment of patients in the COVID-19 pandemic. Such materials must also contain certain express representations and disclaimers, which generally include: (1) A disclaimer that the mask is not FDA cleared or approved; and (2) Language regarding authorization of the product by the FDA under an EUA during the COVID-19 pandemic for the duration of the EUA.
Finally, the EUA waives for manufacturers the requirements for good manufacturing practices, including quality system requirements, requirements for unique device identification, and labeling requirements other than those specifically enumerated in the EUA. Accordingly, the FDA’s recent EUA may provide significant benefits to producers and suppliers of face masks during the COVID-19 pandemic through its expansion of the class of entities entitled to liability immunity under the PREP Act Declarations, and its waiver of certain manufacturing, quality, and labeling standards for members of the chain of supply.
This alert does not purport to be a substitute for advice of counsel on specific matters.
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