{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency.\" This guidance describes the factors FDA intends to assess in deciding whether to issue an enforcement policy regarding in vitro diagnostic test manufacturers' offering of certain unapproved in vitro diagnostic tests and unapproved uses of approved in vitro diagnostic tests during a declared emergency.","action":"Notice of availability.","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/2025/09/23/2025-18402.html","cfr_references":[],"citation":"90 FR 45771","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on September 23, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-D-5365"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-09-23","updated_at":"2025-09-23T10:01:20.400-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-5365-0014","allow_late_comments":false,"id":"FDA-2023-D-5365-0014","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-5365","title":"Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2025-18402","effective_on":null,"end_page":45772,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/09/23/2025-18402.xml","html_url":"https://www.federalregister.gov/documents/2025/09/23/2025-18402/consideration-of-enforcement-policies-for-in-vitro-diagnostic-tests-during-a-section-564-declared","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-18402?publication_date=2025-09-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-09-23/2025-18402/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":309,"last_updated":"2026-09-22 14:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-23/pdf/2025-18402.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18402.pdf?1758545116","publication_date":"2025-09-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/09/23/2025-18402.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-2023-D-5365","supporting_documents_count":0,"docket_id":"FDA-2023-D-5365","document_id":"FDA-2023-D-5365-0014","regulation_id_number":null,"title":"Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2025-09-24T16:55:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":45771,"subtype":null,"title":"Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}