The US Food and Drug Administration (FDA) has again revised its guidance relating to face masks and N-95 respirators.
The latest guidance, issued in “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)”, discontinues policies previously published in March 2020 and April 2020.
Stakeholders should be aware the revised enforcement policy includes updates that will affect the selection of alternatives when FDA-cleared and NIOSH-approved N95 respirators are not available. NIOSH is the National Institute for Occupational Safety and Health.
Under April’s guidance, the FDA had allowed flexibility regarding the distribution and use of respirators identified in the Centers for Disease Control and Prevention (CDC) recommendations without compliance to certain regulatory requirements, including submission of a 510(k) under certain circumstances. The FDA also issued emergency use authorizations (EUAs) for certain respirators that it determined met the criteria for issue under Section 564 of the Act. Since the issue of the April guidance, however, the FDA has become aware that certain respirators where not performing adequately, and they therefore needed greater oversight.
The current guidance by the FDA is that FDA-cleared or NIOSH-approved N95 respirators should be used whenever possible. If they are not available, then FDA-authorized respirators should be used before other alternatives. It does not recommend using a respirator that is not FDA-cleared, NIOSH-approved, or authorized by them for emergency use.
The enforcement policy covers respirators, face masks, face shields “intended for a medical purpose”, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. It does not relate to items marketed to the public for general, non-medical purposes, such as use in construction and other industrial applications.
To learn more about the FDA’s enforcement polices relating to face masks and respirators during the COVID-19 pandemic, read our original SafeGuard 075/20.
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