FDA Issues EUA for Face Masks

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To help address the urgent public health concerns caused by shortages of these products, FDA had previously issued an Enforcement Policy found here. That Policy allows for the importation and/or distribution of certain non-FDA-approved masks and respirators when specified criteria are satisfied.

Notably, FDA has now complemented that Enforcement Policy with an Emergency Use Authorization (EUA) directed specifically at face masks. This EUA can be read here. This EUA applies only to face masks. It does not apply to surgical, respirator, or any other type of mask. So long as the conditions for authorization set forth in the EUA are complied with, the face is deemed to be an authorized mask without any additional action needed, including any advance submission to, or review and approval by, FDA.

Under the EUA, FDA defines a “face mask” as a device, with or without a face shield, that covers the user’s nose and mouth, that may or may not meet fluid barrier filtration efficiency levels; it includes cloth face coverings and may be for single or multiple uses.[1] FDA recognizes that increased availability of face masks helps to meet the needs of the general population while preserving FDA-cleared or authorized surgical masks and N95 and N95 equivalent Face Filtering Respirators for use by health care professionals (HCPs).

Authorization Criteria

Face masks are authorized under the EUA when they are “intended for use by the general public, including HCPs in healthcare settings as PPE, to cover their noses and mouths, in accordance with CDC recommendations” to prevent the spread of the coronavirus during the pandemic.

Similar to the requirements set forth in FDA’s previously issued Enforcement Policy for this type of mask, an authorized mask must:

• be labeled accurately to describe the product as a face mask and include a list of the body contacting materials (which does not include any drugs or biologics);

• be labeled accurately so that it does not claim to be intended for use as a surgical mask or to provide liquid barrier protection, and includes recommendations that would reduce the risk of such use;

• not be labeled in a manner that would misrepresent the mask’s intended use (e.g., the labeling should not state or imply that the product is intended for antimicrobial or antiviral protection or related uses, or for infection prevention or reduction, or particulate filtration).

Assuming that a face mask fully complies with the EUA, FDA may waive or limit, as appropriate, requirements regarding good manufacturing practices, including the quality system requirements, unique device identification and other labeling requirements. It must be emphasized, however, that such waiver or limitation applies only when all of the “Conditions of Authorization” are satisfied. Those Conditions are detailed on pp. 4-5 of the EUA and include but are not limited to the labeling requirements summarized above. In addition:

• manufacturers and distributors must make the required labeling available to each end-user or end-user facility;

• manufacturers and distributors must include instructions for recommended cleaning and/or disinfection materials and processes, if applicable, for their authorized product(s);

• manufacturers must have a process in place for adverse event reporting;

• manufacturers and distributors must maintain records of the entities to which they distribute the face masks and the quantities distributed.

In addition, the EUA also includes numerous advertising and promotion requirements, including but not limited to:

• no implied or express claims that the mask is “safe or effective for the prevention or treatment of patients during the COVID-19 pandemic”

• inclusion of a clear and conspicuous statement that (a) the mask has not been FDA-cleared or approved; (b) the mask has been authorized by FDA under an EUA for use by HCP as PPE to help prevent the spread of infection or illness in healthcare settings and by the general public to help slow the spread of the virus during the COVID-19 pandemic; and (c) the mask is authorized only for the duration of the declaration unless terminated or revoked sooner.

Customs Instructions for declaring under an EUA

U.S. Customs and Border Protection (CBP) has updated instructions for declaring products under an EUA on April 21, 2020 (CSMS #42448725). When importing face masks under this EUA, entry information should be submitted to FDA; however reduced FDA information is required for review.

At the time of entry, Importers should transmit an Intended Use Code of 940.000: Compassionate Use/Emergency Use Device, and an appropriate FDA product code. Under this Intended Use Code, the Affirmations of Compliance for medical devices (such as the Registration, Listing, and Premarket numbers) are optional in ACE.

On April 21, 2020, in the CSMS message, CBP updated its list of products and certain product codes authorized by an EUA. A complete list of product codes may be found in corresponding enforcement policy guidance documents.

A full list of Emergency Use Authorizations currently in place for the COVID-19 emergency is also available on the FDA’s website, which is updated regulatory.

Conclusion

There are now two pathways available for the US importation and distribution of fact masks: FDA’s Enforcement Policy and the EUA. There are pros and cons associated with each that should be considered. FDA’s COVID-19 policies continue to evolve at a fast pace. Arent Fox continues to monitor closely.

[1] In contrast, a “surgical mask” – not covered under the EUA – is a mask that covers the user’s nose and mouth and provides a physical barrier to fluids and particulate materials, and meets certain fluid barrier protection standards and flammability tests.