{"id":"AGY-FED-HEALTH-OTHER-032","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":"Federal Food, Drug, and Cosmetic Act s. 564 (21 U.S.C. 360bbb-3); s. 701(h) guidance; 21 C.F.R. 10.115","instrument":"Policy for Diagnostics Testing in Laboratories Certified To Perform High Complexity Testing Under CLIA Prior to Emergency Use Authorization for Coronavirus Disease-2019 During the Public Health Emergency; Immediately in Effect Guidance, 85 Fed. Reg. 13138 (Mar. 6, 2020)","title":"Policy for Diagnostics Testing in Laboratories Certified To Perform High Complexity Testing Under the Clinical Laboratory Improvement Amendments Prior to Emergency Use Authorization for Coronavirus Disease-2019","dateIssued":"2020-02-29","effective":"2020-02-29 (immediately in effect; FR notice Mar. 6, 2020)","end":"Through the public health emergency (superseded by later versions of the COVID-19 test policy)","startDate":"2020-02-29","endDate":"2021-09-30","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["HC","OTHER"],"addressees":["clinical laboratories certified under CLIA to perform high-complexity testing"],"clause":"On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV).... The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency\u0027s good guidance practices.","enforcement":"FDA premarket requirements under 21 U.S.C. 331, 351-352 relaxed for the described laboratories","functions":["DX diagnostics and laboratory","SC supply chain (test kits)"],"notes":"The first FDA COVID-19 policy; predicate for hospital, academic and commercial laboratories\u0027 in-house tests.","sourceUrl":"https://www.govinfo.gov/content/pkg/FR-2020-03-06/pdf/2020-04630.pdf","snapshot":"","fileExists":true,"fileBytes":210054,"grade":"primary","character":"","description":"","collection":"AGY-FED-HEALTH-OTHER","url":"/library/AGY-FED-HEALTH-OTHER-032","exhibitUrl":"/exhibit/AGY-FED-HEALTH-OTHER-032","citation":"Food and Drug Administration, HHS, Policy for Diagnostics Testing in Laboratories Certified To Perform High Complexity Testing Under CLIA Prior to Emergency Use Authorization for Coronavirus Disease-2019 During the Public Health Emergency; Immediately in Effect Guidance, 85 Fed. Reg. 13138 (Mar. 6, 2020) (Feb. 29, 2020) (Ex. AGY-FED-HEALTH-OTHER-032)","stateName":"","related":["AGY-FED-HEALTH-OTHER-131","AGY-FED-HEALTH-OTHER-033"]}