{"id":"AGY-FED-HEALTH-OTHER-050","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 (letter to Battelle Memorial Institute)","authority":"FD\u0026C Act s. 564(c), (d)","instrument":"Emergency Use Authorization: Battelle Critical Care Decontamination System for decontaminating compatible N95 respirators (issued Mar. 28, 2020; reissued Jan. 21, 2021; revoked June 30, 2021)","title":"Letter of Authorization, Battelle CCDS Critical Care Decontamination System (reissued Jan. 21, 2021)","dateIssued":"2021-01-21","effective":"Original authorization Mar. 28, 2020","end":"2021-06-30 (revocation)","startDate":"2020-03-28","endDate":"2021-06-30","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2"],"types":["SUPPLY","HC"],"addressees":["Battelle Memorial Institute; health care facilities"],"clause":"On March 28, 2020, based on your request, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the emergency use of the Battelle CCDS Critical Care Decontamination System... for use in decontaminating compatible N95 respirators for reuse by healthcare personnel to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of FFRs resulting from the COVID-19 pandemic","enforcement":"Conditions of authorization","functions":["SC supply chain (PPE reuse)","IC infection control"],"notes":"Hospitals nationwide sent N95s to Battelle sites for reuse in 2020-2021; the EUA ended June 30, 2021.","sourceUrl":"https://www.fda.gov/media/136529/download","snapshot":"","fileExists":true,"fileBytes":695306,"grade":"primary","character":"","description":"","collection":"AGY-FED-HEALTH-OTHER","url":"/library/AGY-FED-HEALTH-OTHER-050","exhibitUrl":"/exhibit/AGY-FED-HEALTH-OTHER-050","citation":"Denise M. Hinton, Chief Scientist, FDA (letter to Battelle Memorial Institute), Emergency Use Authorization: Battelle Critical Care Decontamination System for decontaminating compatible N95 respirators (issued Mar. 28, 2020; reissued Jan. 21, 2021; revoked June 30, 2021) (Ex. AGY-FED-HEALTH-OTHER-050)","stateName":"","related":[]}