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:
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. Earloop Face Mask
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 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.
If you have questions concerning this new guidance, please contact the Food, Drug, Medical Device & Cosmetic team at ArentFox Schiff.
[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.
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