{"abstract":"On May 6, 2024, the Food and Drug Administration (FDA, the Agency, or we) issued a final rule amending the definition of \"in vitro diagnostic products\" in FDA's regulations. On March 31, 2025, a federal district court vacated that rule. This final rule reverts to the text of the regulation as it existed prior to the effective date of the May 2024 final rule.","action":"Final rule.","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/2025/09/19/2025-18239.html","cfr_references":[{"chapter":null,"citation_url":null,"part":809,"title":21}],"citation":"90 FR 45134","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective September 19, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-1730"],"dockets":[{"supporting_documents":[{"title":"Tab C - Final Rule - OMB Final Version","document_id":"FDA-2025-N-1730-0005"},{"title":"Tab B - Final Rule - Comparison OMB Original to OMB Final Version","document_id":"FDA-2025-N-1730-0004"},{"title":"Tab A - Final Rule - OMB Original Version","document_id":"FDA-2025-N-1730-0003"},{"title":"Memorandum to FDA DMS on Medical Devices Laboratory Developed Tests Implementation of Vacatur","document_id":"FDA-2025-N-1730-0002"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-09-19","updated_at":"2025-09-19T11:56:51.240-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-1730-0001","allow_late_comments":false,"id":"FDA-2025-N-1730-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":4,"id":"FDA-2025-N-1730","title":"Medical Devices; Laboratory Developed Tests; Implementation of Vacatur"}],"document_number":"2025-18239","effective_on":"2025-09-19","end_page":45136,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/09/19/2025-18239.xml","html_url":"https://www.federalregister.gov/documents/2025/09/19/2025-18239/regulation-identification-number-0910-aj05-medical-devices-laboratory-developed-tests-implementation","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-18239?publication_date=2025-09-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-09-19/2025-18239/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":3829,"last_updated":"2026-05-18 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-19/pdf/2025-18239.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18239.pdf?1758199523","publication_date":"2025-09-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/09/19/2025-18239.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-2025-N-1730","supporting_documents_count":0,"docket_id":"FDA-2025-N-1730","document_id":"FDA-2025-N-1730-0001","regulation_id_number":null,"title":"Medical Devices; Laboratory Developed Tests; Implementation of Vacatur","checked_regulationsdotgov_at":"2025-09-20T17:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":45134,"subtype":null,"title":"Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur","toc_doc":"Laboratory Developed Tests; Implementation of Vacatur","toc_subject":"Medical Devices","topics":["Labeling","Medical devices"],"type":"Rule","volume":90}