{"id":"AGY-FED-HEALTH-OTHER-034","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(h)(1) (publication of EUAs)","instrument":"Notice, Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 85 Fed. Reg. 34638 (June 5, 2020)","title":"Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability","dateIssued":"2020-06-05","effective":"Authorizations effective on their dates of issuance (Mar. 2-Apr. 2020)","end":"Various (decontamination EUAs revoked June 30, 2021; imported FFR EUAs revoked July 6, 2021)","startDate":"2020-06-05","endDate":"2021-06-30","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["SUPPLY","HC"],"addressees":["device manufacturers, importers, distributors, health care personnel"],"clause":"Section 564 of the FD\u0026C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use when the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use.... Certain ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators... issued March 24, 2020","enforcement":"Authorization of otherwise-prohibited interstate commerce in unapproved devices under 21 U.S.C. 331","functions":["SC supply chain","PF production floor","IC infection control (PPE)"],"notes":"Reprints the ventilator, respirator, imported-respirator, Battelle, STERIS and face-shield EUAs of March-April 2020.","sourceUrl":"https://www.govinfo.gov/content/pkg/FR-2020-06-05/pdf/2020-12117.pdf","snapshot":"","fileExists":true,"fileBytes":211027,"grade":"primary","character":"","description":"","collection":"AGY-FED-HEALTH-OTHER","url":"/library/AGY-FED-HEALTH-OTHER-034","exhibitUrl":"/exhibit/AGY-FED-HEALTH-OTHER-034","citation":"Food and Drug Administration, HHS, Notice, Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 85 Fed. Reg. 34638 (June 5, 2020) (Ex. AGY-FED-HEALTH-OTHER-034)","stateName":"","related":["AGY-FED-HEALTH-OTHER-035","AGY-FED-HEALTH-OTHER-033","AGY-FED-HEALTH-OTHER-131"]}