{"id":"AGY-FED-HEALTH-OTHER-035","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)","instrument":"Notice, Process for Publishing Emergency Use Authorizations for Medical Devices During Coronavirus Disease 2019, 85 Fed. Reg. 33686 (June 2, 2020)","title":"Process for Publishing Emergency Use Authorizations for Medical Devices During Coronavirus Disease 2019","dateIssued":"2020-06-02","effective":"2020-06-02","end":"Through the public health emergency","startDate":"2020-06-02","endDate":"2021-09-30","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["OTHER"],"addressees":["device manufacturers and stakeholders"],"clause":"On February 4, 2020, under section 564(b)(1) of the FD\u0026C Act, the Secretary of HHS declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics... On March 2, 2020... personal respiratory protective devices... On March 24, 2020... medical devices, including alternative products use as medical devices, due to shortages during the COVID-19 outbreak","enforcement":"Procedural","functions":["SC supply chain"],"notes":"FDA\u0027s own consolidated recital of the three device declarations.","sourceUrl":"https://www.govinfo.gov/content/pkg/FR-2020-06-02/pdf/2020-11898.pdf","snapshot":"","fileExists":true,"fileBytes":202521,"grade":"primary","character":"","description":"","collection":"AGY-FED-HEALTH-OTHER","url":"/library/AGY-FED-HEALTH-OTHER-035","exhibitUrl":"/exhibit/AGY-FED-HEALTH-OTHER-035","citation":"Food and Drug Administration, HHS, Notice, Process for Publishing Emergency Use Authorizations for Medical Devices During Coronavirus Disease 2019, 85 Fed. Reg. 33686 (June 2, 2020) (Ex. AGY-FED-HEALTH-OTHER-035)","stateName":"","related":["AGY-FED-HEALTH-OTHER-034","AGY-FED-HEALTH-OTHER-033","AGY-FED-HEALTH-OTHER-131"]}