{"id":"FED-183","kind":"order","level":"federal","jurisdiction":"United States","state":"","metro":"","industry":"","agency":"","eco":"","issuer":"Secretary of Health and Human Services","authority":"FD\u0026C Act § 564","instrument":"Emergency Use Authorization Declaration: medical devices, including alternative products used as medical devices","title":"Emergency Use Authorization Declaration, 85 Fed. Reg. 17335 (Mar. 27, 2020)","dateIssued":"2020-03-24","effective":"2020-03-24","end":"through the § 564 emergency","startDate":"2020-03-24","endDate":"2021-09-30","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["EMER","SUPPLY"],"addressees":["FDA; device manufacturers (ventilators, PPE, decontamination systems)"],"clause":"The Office of the Assistant Secretary for Preparedness and Response, HHS, requested that the FDA, HHS, issue an EUA for certain medical devices to allow the Department to take response measures based on information currently available about the virus that causes COVID-19. The determination of a public health emergency, and the declaration that circumstances exist justifying emergency use of certain medical devices by the Secretary of HHS, as described below, enable the FDA Commissioner to issue an EUA for these devices for emergency use under section 564 of the FD\u0026C Act.","enforcement":"Framework","functions":["context for SC (ventilators, face shields, gowns, decontamination)"],"notes":"CONTEXT ONLY.","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":"FED-A","url":"/library/FED-183","exhibitUrl":"/exhibit/FED-183","citation":"Secretary of Health and Human Services, Emergency Use Authorization Declaration: medical devices, including alternative products used as medical devices (Mar. 24, 2020) (Ex. FED-183)","stateName":"","related":["FED-074","FED-184","FED-182","FED-180","FED-181"]}