{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled \"Patient-Matched Guides for Orthopedic Implants.\" This guidance document provides recommendations regarding information that should be included in regulatory submissions for patient-matched guides for orthopedic implants. This guidance also provides recommendations that manufacturers should consider when developing their design process for these device types. This guidance is intended to promote clarity and transparency as to expectations regarding submission recommendations for orthopedic patient-matched guides. Following such recommendations may increase efficiency and consistency in review.","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/2026/05/07/2026-09023.html","cfr_references":[],"citation":"91 FR 24876","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 7, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-D-2370"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-05-07","updated_at":"2026-05-07T10:02:12.066-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-2370-0007","allow_late_comments":false,"id":"FDA-2023-D-2370-0007","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-2370","title":"Patient-Matched Guides to Orthopedic Implants; Draft Guidance for Industry and Food and Drug Administration Staff; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2026-09023","effective_on":null,"end_page":24878,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/05/07/2026-09023.xml","html_url":"https://www.federalregister.gov/documents/2026/05/07/2026-09023/patient-matched-guides-for-orthopedic-implants-guidance-for-industry-and-food-and-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-09023?publication_date=2026-05-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-05-07/2026-09023/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":385,"last_updated":"2026-05-28 12:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-07/pdf/2026-09023.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-09023.pdf?1778071520","publication_date":"2026-05-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/05/07/2026-09023.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-2370","supporting_documents_count":0,"docket_id":"FDA-2023-D-2370","document_id":"FDA-2023-D-2370-0007","regulation_id_number":null,"title":"Patient-Matched Guides to Orthopedic Implants; Draft Guidance for Industry and Food and Drug Administration Staff; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2026-05-08T12:55:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":24876,"subtype":null,"title":"Patient-Matched Guides for Orthopedic Implants; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Patient-Matched Guides for Orthopedic Implants","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}