{"abstract":"The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Pfizer Inc. for the Lucira by Pfizer COVID-19 & Flu Test and Lucira by Pfizer COVID-19 & Flu Home Test. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2026/01/02/2025-24155.html","cfr_references":[],"citation":"91 FR 145","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The revocation of the Authorizations for the Pfizer Inc.'s Lucira by Pfizer COVID-19 & Flu Test and Lucira by Pfizer COVID-19 & Flu Home Test were effective as of October 22, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-N-0150"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-01-02","updated_at":"2026-01-02T10:55:44.256-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-N-0150-0018","allow_late_comments":false,"id":"FDA-2022-N-0150-0018","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-N-0150","title":"Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability"}],"document_number":"2025-24155","effective_on":"2025-10-22","end_page":148,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/01/02/2025-24155.xml","html_url":"https://www.federalregister.gov/documents/2026/01/02/2025-24155/revocation-of-two-authorizations-of-emergency-use-of-in-vitro-diagnostic-devices-for-detection-andor","images":{"EN02JA26.001":{"large":"https://img.federalregister.gov/EN02JA26.001/EN02JA26.001_large.png","medium":"https://img.federalregister.gov/EN02JA26.001/EN02JA26.001_medium.png","original_size":"https://img.federalregister.gov/EN02JA26.001/EN02JA26.001_original_size.png"},"EN02JA26.000":{"large":"https://img.federalregister.gov/EN02JA26.000/EN02JA26.000_large.png","medium":"https://img.federalregister.gov/EN02JA26.000/EN02JA26.000_medium.png","original_size":"https://img.federalregister.gov/EN02JA26.000/EN02JA26.000_original_size.png"}},"images_metadata":{"EN02JA26.001":{"large":{"identifier":"EN02JA26.001","content_type":"image/png","size":109564,"width":823,"sha":"4239db5b21ac4c3da0dbc7994f997150","url":"https://img.federalregister.gov/EN02JA26.001/EN02JA26.001_large.png","height":1189},"medium":{"identifier":"EN02JA26.001","content_type":"image/png","size":31550,"width":398,"sha":"0ee8f1911c1b605057e31fe1f69d7b88","url":"https://img.federalregister.gov/EN02JA26.001/EN02JA26.001_medium.png","height":575},"original_size":{"identifier":"EN02JA26.001","content_type":"image/png","size":74202,"width":1505,"sha":"c65ff09c45d15db1c3b30d336eaf4400","url":"https://img.federalregister.gov/EN02JA26.001/EN02JA26.001_original_size.png","height":2174}},"EN02JA26.000":{"large":{"identifier":"EN02JA26.000","content_type":"image/png","size":109751,"width":823,"sha":"7699ba8a9befabf7fc9c8caecfaf66d7","url":"https://img.federalregister.gov/EN02JA26.000/EN02JA26.000_large.png","height":1187},"medium":{"identifier":"EN02JA26.000","content_type":"image/png","size":30715,"width":397,"sha":"12ebac6ccf798d379c282463cc15d10e","url":"https://img.federalregister.gov/EN02JA26.000/EN02JA26.000_medium.png","height":573},"original_size":{"identifier":"EN02JA26.000","content_type":"image/png","size":73002,"width":1501,"sha":"b8b3cdabf2090415b0df66587d8c169f","url":"https://img.federalregister.gov/EN02JA26.000/EN02JA26.000_original_size.png","height":2165}}},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-24155?publication_date=2026-01-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-01-02/2025-24155/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":453,"last_updated":"2026-09-22 06:15:08 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-01-02/pdf/2025-24155.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-24155.pdf?1767188710","publication_date":"2026-01-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/01/02/2025-24155.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2022-N-0150","supporting_documents_count":0,"docket_id":"FDA-2022-N-0150","document_id":"FDA-2022-N-0150-0018","regulation_id_number":null,"title":"Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability","checked_regulationsdotgov_at":"2026-01-03T19:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":145,"subtype":null,"title":"Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability","toc_doc":"Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID19","toc_subject":null,"topics":[],"type":"Notice","volume":91}