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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FDA Issues Revised Face Mask and Respiratory Enforcement Policy SafeGuardS.
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