FDA issues additional guidance on masks

This latest guidance, dated September 5, 2023, is the latest update on the agency’s evolving stance.[1] To understand the agency’s new changes, it’s important to know these two definitions:

  • Face mask Masks, with or without face shields, cover the user’s nose and mouth and may or may not meet a fluid barrier level or filtration efficiency level. Masks are used by the general public and health care professionals (HCPs) for source control[2] according to CDC recommendations.
  • Barrier face shield As described in ASTM F3502, a face shield is a product worn on the face, specifically covering at least the wearer’s nose and mouth, with the primary purpose of providing power control and providing Particulate filtration to reduce the amount of inhaled particulate matter.

The FDA has long held that face masks are devices used to diagnose disease or other conditions or to cure, mitigate, treat or prevent disease. Therefore, masks intended to prevent transmission of infectious disease (i.e., prevent transmission of coronavirus) are devices subject to FDA regulation. However, if masks are marketed for non-medical purposes, such as use in construction and other applications, they are not devices and therefore are not subject to FDA regulation. .

In this new guidance, FDA is continuing its enforcement discretion policy of not objecting to the distribution and use of masks and face shields, with or without face shields (excluding respirators). toxic), intended for medical purposes where the product does not pose an undue risk. This applies whether they are used by healthcare workers or the general public.

The FDA currently states that face masks will not create an undue risk in the following situations:

  • The product includes a label that accurately describes it as a mask (as opposed to a face shield, surgical mask, or respirator) and includes a list of materials that come into contact with the body.
  • Non-NIOSH approved filtering respirators (FFRs) must be separated from NIOSH approved FFRs and clearly identified as respirators for use as source control only.
  • The product does not contain any drugs, biologics or nanoparticles.
  • The product includes a label advising against use in certain environments, such as recommending against use in any surgical facility.
  • The product is not intended for any use that may present unreasonable risks; for example, uses for antimicrobial or antiviral protection, preventing or reducing infections, or related uses; and the labeling does not include use for particle filtration.

The new guidance notes that Emergency Use Authorizations (EUAs) have been issued for certain medical-grade face masks for use by the general public, and FDA will continue to issue those EUAs for the time being. in. For new EUAs for face masks, the guidance outlines the conditions that FDA will require in the future.

If you have questions regarding this new guidance, please contact the Food, Pharmaceutical, Medical Device & Cosmetics team at ArentFox Schiff.


[1] Previous guidances were issued in April 2020, May 2020, September 2021, and March 2023. In the Agency’s view, these guidances are designed to help address concerns urgent health concerns by clarifying the regulatory context for masks and face shields and helping to expand their coverage. availability of these devices for use by the general public and healthcare professionals (HCPs) in healthcare settings.

[2] Source control refers to the use of masks or face shields over the mouth and nose to block that source of infection.

individual’s respiratory secretions to help prevent transmission from people who may or may not be infected

symptoms of an infectious disease.

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