FDA Guidance Details Enforcement Policies for Face Masks and Respirators During COVID-19 Pandemic
The Food and Drug Administration on March 25 issued a new guidance document detailing its enforcement policy for face masks and respirators during the COVID-19 public health emergency. The policy is intended to “help expand the availability of general use…
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face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for health care professionals during this pandemic.” It includes information on enforcement for face masks and respirators not intended for medical purposes, face masks intended for medical purposes but not intended to provide liquid barrier protection, and surgical masks. It also sets out FDA’s intended approach for emergency use authorizations for masks and respirators, including for reprocessing of filtering facepiece respirators.