{"id":"AGY-FED-HEALTH-OTHER-044","kind":"context","level":"federal","jurisdiction":"United States (federal); Food and Drug Administration, Center for Devices and Radiological Health","state":"","metro":"","industry":"","agency":"FED-HEALTH-OTHER","eco":"","issuer":"Food and Drug Administration, CDRH","authority":"FD\u0026C Act ss. 510(k), 519, 520(f), 564; 21 C.F.R. 878.4040; enforcement discretion","instrument":"Guidance: Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Mar. 25, 2020; revised Apr. 2020, May 2020, Sept. 2021; superseded Sept. 5, 2023)","title":"Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency","dateIssued":"2020-03-25","effective":"2020-03-25 (immediately in effect)","end":"Superseded by the Sept. 5, 2023 policy; in force throughout 2020-2021","startDate":"2020-03-25","endDate":"2023-09-05","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["SUPPLY","MASK","OTHER"],"addressees":["manufacturers, importers and distributors of face masks, face shields and respirators"],"clause":"This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19... FDA does not intend to object to the distribution and use of face masks, with or without a face shield... that are intended for a medical purpose... without compliance with... premarket notification requirements... where the face mask does not create an undue risk","enforcement":"Enforcement discretion under 21 U.S.C. 331 for the listed premarket, registration and labeling requirements","functions":["SC supply chain (masks)","PF production floor (converted apparel and textile lines)","IC infection control"],"notes":"The saved file is FDA\u0027s Sept. 5, 2023 superseding version, which recites the March 2020 policy\u0027s history;","sourceUrl":"https://www.fda.gov/media/136449/download","snapshot":"","fileExists":true,"fileBytes":540497,"grade":"secondary","character":"context","description":"","collection":"AGY-FED-HEALTH-OTHER","url":"/library/AGY-FED-HEALTH-OTHER-044","exhibitUrl":"/exhibit/AGY-FED-HEALTH-OTHER-044","citation":"Food and Drug Administration, CDRH, Guidance: Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Mar. 25, 2020; revised Apr. 2020, May 2020, Sept. 2021; superseded Sept. 5, 2023) (Ex. AGY-FED-HEALTH-OTHER-044)","stateName":"","related":["AGY-FED-HEALTH-OTHER-043"]}