The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for health care professionals during this pandemic.
This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the Secretary in accordance with section 319(a)(2) of the Public Health Services (PHS) Act.
Given this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency's good guidance practices. (Press Release)
C.D.C. says all Americans should wear masks. Trump says the rule is voluntary. Senior officials at the C.D.C. have been pushing the president for days to advise everyone — even people who appear to be healthy — to wear a mask or a scarf that covers their mouth and nose when shopping at the grocery store or while in other public places.
The Pentagon is considering letting two Navy hospital ships dispatched to New York and California take patients who test positive for the novel coronavirus, Defense Department officials said Friday. A decision could come in the next few days.