{"id":"AGY-FED-HEALTH-OTHER-049","kind":"order","level":"federal","jurisdiction":"United States (federal); Food and Drug Administration","state":"","metro":"","industry":"","agency":"FED-HEALTH-OTHER","eco":"","issuer":"Denise M. Hinton, Chief Scientist, FDA","authority":"FD\u0026C Act s. 564(c), (d)","instrument":"Emergency Use Authorization: Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (issued Mar. 24, 2020; reissued Mar. 28, 2020, May 7, 2020 and Mar. 24, 2021; revoked July 6, 2021)","title":"Letter of Authorization, Imported Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (reissued Mar. 24, 2021)","dateIssued":"2021-03-24","effective":"Original authorization Mar. 24, 2020","end":"2021-07-06 (revocation noticed at 86 Fed. Reg. 48712 (Aug. 31, 2021))","startDate":"2020-03-24","endDate":"2021-07-06","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["SUPPLY","HC"],"addressees":["manufacturers, importers, distributors, health care personnel"],"clause":"On March 24, 2020, in response to this public health emergency and concerns about filtering facepiece respirator (FFR or respirator) availability, FDA authorized the emergency use of certain imported disposable FFRs that are not approved by NIOSH... for use in healthcare settings by HCP to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages","enforcement":"Conditions of authorization; interstate commerce otherwise barred by 21 U.S.C. 331","functions":["SC supply chain (imports)","IC infection control","PT ports and customs (FDA import review)"],"notes":"Reached importers, freight forwarders, distributors and every health-care buyer; its revocation on July 6, 2021 is a Q3 2021 supply-chain change.","sourceUrl":"https://www.fda.gov/media/136403/download","snapshot":"","fileExists":true,"fileBytes":902977,"grade":"primary","character":"","description":"","collection":"AGY-FED-HEALTH-OTHER","url":"/library/AGY-FED-HEALTH-OTHER-049","exhibitUrl":"/exhibit/AGY-FED-HEALTH-OTHER-049","citation":"Denise M. Hinton, Chief Scientist, FDA, Emergency Use Authorization: Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (issued Mar. 24, 2020; reissued Mar. 28, 2020, May 7, 2020 and Mar. 24, 2021; revoked July 6, 2021) (Ex. AGY-FED-HEALTH-OTHER-049)","stateName":"","related":["AGY-FED-HEALTH-OTHER-051","AGY-FED-HEALTH-OTHER-053","AGY-FED-HEALTH-OTHER-054"]}