{"id":"AGY-FED-HEALTH-OTHER-051","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: Ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors and ventilator accessories (Mar. 24, 2020)","title":"Letter of Authorization to Manufacturers and Other Stakeholders: Ventilators","dateIssued":"2020-03-24","effective":"2020-03-24","end":"Through the public health emergency (transition per 88 Fed. Reg. 15417)","startDate":"2020-03-24","endDate":"2021-09-30","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["SUPPLY","HC"],"addressees":["manufacturers and other stakeholders"],"clause":"This Emergency Use Authorization (EUA) is being issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in healthcare settings to treat patients during the Coronavirus Disease 2019 (COVID-19) pandemic.... the scope of this authorization is limited to the use of authorized ventilators, ventilator tubing connectors, and ventilator accessories listed in Appendix B for use in healthcare settings to treat patients during the COVID-19 pandemic","enforcement":"Conditions of authorization; 21 U.S.C. 331","functions":["SC supply chain","PF production floor (automakers and others converted to ventilator production)","IP inpatient surge capacity"],"notes":"The instrument under which General Motors, Ford and other manufacturers produced ventilators under DPA orders.","sourceUrl":"https://www.fda.gov/media/136423/download","snapshot":"","fileExists":true,"fileBytes":406596,"grade":"primary","character":"","description":"","collection":"AGY-FED-HEALTH-OTHER","url":"/library/AGY-FED-HEALTH-OTHER-051","exhibitUrl":"/exhibit/AGY-FED-HEALTH-OTHER-051","citation":"Denise M. Hinton, Chief Scientist, FDA, Emergency Use Authorization: Ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors and ventilator accessories (Mar. 24, 2020) (Ex. AGY-FED-HEALTH-OTHER-051)","stateName":"","related":["AGY-FED-HEALTH-OTHER-049","AGY-FED-HEALTH-OTHER-053","AGY-FED-HEALTH-OTHER-054"]}