COVID-19 respirator, face mask guidance gets update from FDA

The Food and Drug Administration yesterday released an updated enforcement policy related to face masks, barrier face coverings, face shields, surgical masks and respirators for the duration of the COVID-19 public health emergency. The updates are intended to expand these products’ availability to the general public and health care personnel. The revised guidance adds barrier face coverings to its current face mask policy, allowing for the distribution and use of face masks and barrier face coverings for medical purpose even though those products may not be in compliance with certain regulatory requirements — so long as the use of those products does not create an undue risk. In an additional effort to bolster supply, the FDA states that it generally does not intend to object to the distribution of stockpiled, non-NIOSH-approved respirators to be used as face masks for source control where such use does not create an undue risk. For examples of when undue risk is not created, please reference pages 8 and 9 of the enforcement policy. This policy will remain in effect until the end of the COVID-19 public health emergency.