{"id":"AGY-FED-HEALTH-OTHER-052","kind":"order","level":"federal","jurisdiction":"United States (federal); Food and Drug Administration","state":"","metro":"","industry":"","agency":"FED-HEALTH-OTHER","eco":"","issuer":"Jacqueline A. O\u0027Shaughnessy, Acting Chief Scientist, FDA (letter to CDC)","authority":"FD\u0026C Act s. 564(c), (d), (g)(2)(C)","instrument":"Emergency Use Authorization: NIOSH-approved air purifying respirators for health care personnel (issued Mar. 2, 2020; reissued Mar. 28, 2020 and July 12, 2021)","title":"Letter of Authorization to CDC, NIOSH-Approved Air Purifying Respirators (reissued July 12, 2021)","dateIssued":"2021-07-12","effective":"Original authorization Mar. 2, 2020; reissuance July 12, 2021 removed decontaminated and expired respirators from the scope","end":"Through the public health emergency","startDate":"2020-03-02","endDate":"2021-09-30","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["SUPPLY","HC"],"addressees":["health care personnel and facilities; CDC"],"clause":"the FDA determined it is necessary to reissue the March 28, 2020, letter in order to amend the Scope of Authorization (Section II) to remove FFRs that were NIOSH-approved but have since passed the manufacturers\u0027 recommended shelf-life and to remove the emergency use authorization of decontaminated respirators from the scope of authorization.... CDC no longer recommends that HCPs use decontaminated or non-NIOSH-approved FFRs","enforcement":"Conditions of authorization","functions":["SC supply chain","IC infection control"],"notes":"A Q3 2021 instrument: from July 12, 2021 health-care employers could no longer rely on decontaminated or expired N95s.","sourceUrl":"https://www.fda.gov/media/135763/download","snapshot":"","fileExists":true,"fileBytes":456482,"grade":"primary","character":"","description":"","collection":"AGY-FED-HEALTH-OTHER","url":"/library/AGY-FED-HEALTH-OTHER-052","exhibitUrl":"/exhibit/AGY-FED-HEALTH-OTHER-052","citation":"Jacqueline A. O\u0027Shaughnessy, Acting Chief Scientist, FDA (letter to CDC), Emergency Use Authorization: NIOSH-approved air purifying respirators for health care personnel (issued Mar. 2, 2020; reissued Mar. 28, 2020 and July 12, 2021) (Ex. AGY-FED-HEALTH-OTHER-052)","stateName":"","related":[]}