FDA's Policy in Response to Face Mask and Respirator Shortages Resulting from COVID-19
In the confusion brought about by efforts to address the mass shortages of face masks and respirators for both public and health care professionals, FDA’s recent guidance document, Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency is welcome. This guidance aims to expand the availability of general use face masks for the public and facepiece respirators for healthcare professionals during the COVID-19 public health emergency. Like the other recent FDA policies to address the shortages caused by the pandemic, this policy is effective only during the duration of the public health emergency.
The first part of the guidance identifies and defines the different categories of “face masks” subject to the policy, and the level of protection each type provides, from masks that are not intended to provide filtration or a fluid barrier, to those designed to protect against microorganisms, body fluids and particulate material. The different categories are:
- Face Mask: Covers the user’s nose and mouth; may or may not meet fluid barrier or filtration efficiency levels
- Surgical Mask: Covers the user’s nose and mouth, provides a physical barrier to fluids and particulate materials; meets certain fluid barrier protection standards and flammability tests
- Filtering Facepiece Respirator (FFR): Covers the user’s nose and mouth, disposable half face-piece non-powered; air-purifying; intended to help reduce exposure to pathogenic biological airborne particulates