{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled \"Unique Device Identifier (UDI) Requirements for Combination Products.\" This draft guidance is intended to assist industry and FDA staff in understanding how FDA's unique device identifier (UDI) requirements apply to combination products with device constituent parts.","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/2025/06/26/2025-11806.html","cfr_references":[],"citation":"90 FR 27310","comment_url":null,"comments_close_on":"2025-09-24","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by September 24, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-D-0176"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-06-26","updated_at":"2025-06-26T10:57:24.218-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-D-0176-0001","allow_late_comments":false,"id":"FDA-2025-D-0176-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-D-0176","title":"Unique Device Identifier (UDI) Requirements for Combination Products; Draft Guidance for Industry and FDA Staff; Availability"}],"document_number":"2025-11806","effective_on":null,"end_page":27312,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/06/26/2025-11806.xml","html_url":"https://www.federalregister.gov/documents/2025/06/26/2025-11806/unique-device-identifier-requirements-for-combination-products-draft-guidance-for-industry-and-fda","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-11806?publication_date=2025-06-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-06-26/2025-11806/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":900,"last_updated":"2026-06-17 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-26/pdf/2025-11806.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11806.pdf?1750855520","publication_date":"2025-06-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/06/26/2025-11806.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-D-0176","supporting_documents_count":0,"docket_id":"FDA-2025-D-0176","document_id":"FDA-2025-D-0176-0001","regulation_id_number":null,"title":"Unique Device Identifier (UDI) Requirements for Combination Products; Draft Guidance for Industry and FDA Staff; Availability","checked_regulationsdotgov_at":"2025-06-27T17:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27310,"subtype":null,"title":"Unique Device Identifier Requirements for Combination Products; Draft Guidance for Industry and FDA Staff; Availability","toc_doc":"Unique Device Identifier Requirements for Combination Products","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}