{"id":"AGY-FED-HEALTH-OTHER-036","kind":"order","level":"federal","jurisdiction":"United States (federal); Department of Health and Human Services, Office of the Secretary","state":"","metro":"","industry":"","agency":"FED-HEALTH-OTHER","eco":"","issuer":"Alex M. Azar II, Secretary of Health and Human Services","authority":"FD\u0026C Act s. 564(b)(1)(C) (21 U.S.C. 360bbb-3(b)(1)(C))","instrument":"Emergency Use Authorization Declaration (medical devices, including alternative products used as medical devices), 85 Fed. Reg. 17335 (Mar. 27, 2020)","title":"Emergency Use Authorization Declaration","dateIssued":"2020-03-24","effective":"2020-03-24 (determination effective Feb. 4, 2020)","end":"Terminated by HHS notice effective in 2026 (post-period); in force throughout 2020-2021","startDate":"2020-03-24","endDate":"2021-09-30","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["SUPPLY","EMER"],"addressees":["FDA; device manufacturers and users"],"clause":"I declared that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, pursuant to section 564 of the FD\u0026C Act, subject to the terms of any authorization issued under that section.","enforcement":"Predicate for FDA authorizations under 21 U.S.C. 360bbb-3(c)","functions":["SC supply chain","PF production floor (converted manufacturing)"],"notes":"The March 24, 2020 device declaration underlying the ventilator, face-shield, gown, surgical-mask and decontamination EUAs.","sourceUrl":"https://www.govinfo.gov/content/pkg/FR-2020-03-27/pdf/2020-06541.pdf","snapshot":"","fileExists":true,"fileBytes":205583,"grade":"primary","character":"","description":"","collection":"AGY-FED-HEALTH-OTHER","url":"/library/AGY-FED-HEALTH-OTHER-036","exhibitUrl":"/exhibit/AGY-FED-HEALTH-OTHER-036","citation":"Alex M. Azar II, Secretary of Health and Human Services, Emergency Use Authorization Declaration (medical devices, including alternative products used as medical devices), 85 Fed. Reg. 17335 (Mar. 27, 2020) (Mar. 24, 2020) (Ex. AGY-FED-HEALTH-OTHER-036)","stateName":"","related":["AGY-FED-HEALTH-OTHER-037","AGY-FED-HEALTH-OTHER-039","AGY-FED-HEALTH-OTHER-038","AGY-FED-HEALTH-OTHER-040"]}