{"id":"AGY-FED-HEALTH-OTHER-048","kind":"order","level":"federal","jurisdiction":"United States (federal); Food and Drug Administration","state":"","metro":"","industry":"","agency":"FED-HEALTH-OTHER","eco":"","issuer":"Food and Drug Administration, HHS","authority":"FD\u0026C Act s. 564(g)(2), (h)(1)","instrument":"Notice, Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 86 Fed. Reg. 48712 (Aug. 31, 2021)","title":"Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability","dateIssued":"2021-08-31","effective":"Decontamination and bioburden-reduction EUAs revoked June 30, 2021; imported FFR and China FFR umbrella EUAs revoked July 6, 2021","end":"Revocations effective as stated","startDate":"2021-06-30","endDate":"2021-09-30","quarters":["2021Q3"],"types":["SUPPLY","HC"],"addressees":["holders of the fifteen revoked EUAs; health care facilities using decontaminated or imported respirators"],"clause":"The Food and Drug Administration (FDA) is announcing the revocation of 15 Emergency Use Authorizations (EUAs) (the Authorizations), including 12 Authorizations for decontamination systems for personal protective equipment, 1 Authorization for a bioburden reduction system for personal protective equipment, and 2 umbrella Authorizations for certain imported, non-NIOSH... approved disposable respirators.... DATES: The Authorizations for the decontamination and bioburden reduction systems are revoked as of June 30, 2021. The Authorizations for the China FFR Authorization and Imports FFR Authorization are revoked as of July 6, 2021.","enforcement":"Interstate commerce in the formerly authorized products again subject to 21 U.S.C. 331","functions":["SC supply chain (PPE)","IC infection control","WH warehouse (inventory of imported respirators)"],"notes":"A Q3 2021 federal instrument that changed the PPE supply chain of every health-care employer and of the importers, distributors and decontamination contractors that had operated under the revoked EUAs.","sourceUrl":"https://www.govinfo.gov/content/pkg/FR-2021-08-31/pdf/2021-18777.pdf","snapshot":"","fileExists":true,"fileBytes":2505067,"grade":"primary","character":"","description":"","collection":"AGY-FED-HEALTH-OTHER","url":"/library/AGY-FED-HEALTH-OTHER-048","exhibitUrl":"/exhibit/AGY-FED-HEALTH-OTHER-048","citation":"Food and Drug Administration, HHS, Notice, Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 86 Fed. Reg. 48712 (Aug. 31, 2021) (Ex. AGY-FED-HEALTH-OTHER-048)","stateName":"","related":[]}