[Letter from Denise M. Hinton to Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators; Health Care Personnel; Hospital Purchasing Departments and Distributors; Importers and Commercial Wholesalers; and Any Other Applicable Stakeholders, March 28, 2020] [open pdf - 209KB]
From the Letter: "On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19 [Coronavirus Disease 2019]. Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of HHS then declared on March 2, 2020, that circumstances exist justifying the authorization of emergency use of personal respiratory protective devices during the Coronavirus Disease 2019 (COVID-19) outbreak, subject to the terms of any authorization issued under that Section."
U.S. Food and Drug Administration: https://www.fda.gov/