In general, masks are used by the general public and health care personnel to prevent the spread of infection or illness. This page is for people and organizations who are new to working with the FDA. To help expand the availability of face masks and surgical masks, the FDA is providing regulatory flexibility, as described in our policy for face masks and surgical masks that is in effect during the COVID-19 pandemic.
Q: Which masks are medical devices regulated by the FDA? A. Face masks marketed to the general public for general non-medical purposes, such as use in construction and other industrial applications, are not medical devices. Face masks, when they are intended for a medical purpose such as source control (including uses related to COVID-19) and surgical masks are medical devices. Q: Is there a difference between a mask and a respirator? A: Masks and respirators both cover a wearer’s nose and mouth, but they differ in several aspects. Masks are loose fitting and may not provide full protection from breathing in airborne pathogens, such as viruses. Face masks (non-surgical masks) may not provide protection from fluids or may not filter particles, needed to protect against pathogens, such as viruses. They are not for surgical use and are not considered personal protective equipment. Surgical masks are fluid-resistant, disposable, and loose-fitting devices that create a physical barrier between the mouth and nose of the wearer and the immediate environment. They are for use in surgical settings and do not provide full protection from inhalation of airborne pathogens, such as viruses. Respirators are personal protective equipment that tightly fit the face and filter airborne particles to protect health care workers. They provide a higher level of protection against viruses and bacteria when properly fit-tested. This document does not address respirators. This CDC infographic explains the differences between surgical masks and N95 respirators. Q: I am interested in manufacturing face masks for COVID-19. What do I need to do? A: It will depend on the type of mask you want to manufacture. Masks for non-medical purposes are not medical devices and are not regulated by the FDA. The FDA has issued an EUA for face masks that meet certain criteria, including cloth face coverings recommended by the Centers for Disease Control (CDC). During the COVID-19 public health emergency, a face mask for a medical purpose that is intendedfor use as source control, is not labeled as a surgical mask, and is not intended to provide liquid barrier protection, may be authorized under the "umbrella" EUA for face masks without submitting documentation to the FDA if the face mask meets the eligibility requirements. A face mask authorized under this EUA must comply with the Conditions of Authorization (Section IV) of the EUA. Please note that this EUA does not authorize face masks for use as personal protective equipment.
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