This latest guidance, dated September 5, 2023, is the most recent iteration of the agency’s evolving views.[1] To understand the agency’s new changes, it is important to be aware of these two definitions:

• Face Mask – A mask, 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.  Face masks are for use by the general public and health care personnel (HCP) as source control[2] in accordance with CDC recommendations.
• Barrier Face Covering – As described in the ASTM F3502 standard, a barrier face covering is a product worn on the face, specifically covering at least the wearer’s nose and mouth, with the primary purpose of providing source control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate matter.

FDA has long held that face masks are devices when they are “intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease.”  Thus face masks that are intended for the prevention of infectious disease transmission – i.e. to prevent the transmission of the coronavirus – are devices subject to FDA regulation. However, if face masks are marketed for non-medical purposes, such as use in construction and other applications, they are not devices and hence not subject to FDA regulation.

In this new guidance, FDA is continuing its enforcement discretion policy in not objecting to the distribution and use of face masks and barrier face coverings, with or without a face shield (not including respirators), that are intended for a medical purpose where the product “does not create an undue risk.”  This applies whether they are to be used by medical personnel or the general public.

FDA currently states that face masks would not create “an undue risk” in the following circumstances:

• The product includes labeling that accurately describes it as a face mask (as opposed to a barrier face covering, surgical mask, or respirator) and includes a list of the body-contacting materials.
• Non-NIOSH-approved filtering facepiece respirators (FFRs) should be segregated from NIOSH-approved FFRs and clearly identified as face masks for use as source control only.
• The product does not include any drugs, biologics, or nanoparticles.
• The product includes labeling that recommends against use in certain environments, such as recommendations against use in any surgical settings.
• The product is not intended for any use that would create an undue risk; for example, a use for antimicrobial or antiviral protection, infection prevention or reduction, or related uses; and the labeling does not include uses for particulate filtration.

The new guidance noted that Emergency Use Authorizations (EUAs) have been issued for certain face masks for medical purposes for use by the general public, and the FDA will continue to issue such EUAs for the present time.  With respect to new EUAs for face masks, the guidance outlines the conditions that the FDA will require in the future.

[1] Previous guidances were issued on April 2020, May 2020, September 2021, and March 2023.  In the Agency’s view, these guidances are designed to help address “urgent health concerns by clarifying the regulatory landscape of face masks and barrier face coverings and helping to expand the availability of these devices for use by the general public and healthcare personnel (HCP) in healthcare settings ….”

[2] “Source control” refers to the use of a face mask or barrier face covering over the mouth and nose to contain that

individual’s respiratory secretions to help prevent transmission from infected individuals who may or may not have

symptoms of an infectious disease.