The US Food and Drug Administration (FDA) has issued updated guidance to provide a policy to help expand the availability of face masks, barrier face coverings and face shields for the general public, including healthcare personnel (HCP), and surgical masks and particulate filtering facepiece respirators (FFRs) (including N95 respirators) for HCP for the duration of the COVID-19 public health emergency.
There are many products marketed in the United States as “face masks” that offer a range of protection against potential health hazards. Face masks, barrier face coverings, face shields and respirators are regulated by FDA when they meet the definition of a device under section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Generally, face masks, barrier face coverings and face shields fall within this definition when they are intended for a medical purpose, including for use by Healthcare Professionals (HCP).
Face masks that are not intended for a medical purpose are not medical devices, as described in further detail below. Air-purifying respirators (FDA also considers face mask and surgical mask accessories that are intended to help hold the mask to the face (e.g., surgical mask strap holders, tension release bands) to fall within the scope of this guidance. Respirator accessories are not included in the scope of this guidance. As used in this guidance “intended for a medical purpose” means that the device is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease and, therefore, meets the definition of “device” set forth in section 201(h)(1) of the FD&C Act.
FDA is taking steps to expand the availability of face masks, barrier face coverings, face shields, surgical masks and respirators, and believes the policy set forth in this guidance may help address the urgent public health concerns caused by shortages of such products by taking a risk-based approach and clarifying the policies that FDA intends to apply to these products, including their associated indications and claims.