FDA Updates Guidance on Enforcement Policy for Face Masks During Pandemic
The FDA recently updated a guidance document outlining its enforcement policy for face masks, barrier face coverings, face shields, surgical masks and respirators during the COVID-19 pandemic, it said in a notice released Oct. 5. The latest version covers barrier…
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face coverings intended for a medical purpose but not intended to provide liquid barrier protection, including FDA’s technical and labeling recommendations. It also removes reference to use of alternatives when FDA-cleared or NIOSH-approved N95 respirators are not available because the Centers for Disease Control and Prevention (CDC) and the FDA now recommend that healthcare facilities should not be using crisis capacity strategies at this time, and adds a policy that, during the public health emergency, the agency generally does not intend to object to stockpiled, non-NIOSH-approved disposable filtering facepiece respirators (FFRs) being further distributed and used as face masks for source control (as opposed to use as FFRs for respiratory protection) by the public and healthcare providers where such use does not create an undue risk in light of the public health emergency.