federal_register: 2022-24072

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2022-24072 Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability Notice The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute (Cleveland Clinic) for the Cleveland Clinic SARS-CoV-2 Assay and SelfCheck COVID-19 TaqPath Multiplex PCR. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document. 2022-11-04 2022 11 https://www.federalregister.gov/documents/2022/11/04/2022-24072/revocation-of-two-authorizations-of-emergency-use-of-in-vitro-diagnostic-devices-for-detection-andor https://www.govinfo.gov/content/pkg/FR-2022-11-04/pdf/2022-24072.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute (Cleveland Clinic) for the...  

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